123
1 Benedictine University Cosmetic Chemistry Course Topics Date Module Focus Speaker Company 11-Sep Introduction to Cosmetics - Trends, Size of Industry, Products, Chemical Classes, Raw Materials Used, Formulation Types Scott Wenzel Kimberly-Clark 18-Sep Surfactants - Types of Surfactants, Surfactant Chemistry, Formulation of Surfactants Tom Schoenberg Schoenberg Consulting, Inc. 25-Sep Emulsions - Types of Emulsions, Emulsion Theory, Formulation of Emulsions Perry Romanowski Alberto Culver 2-Oct Formulation Module - What is Formulating, How to Formulate Various Types of Products in the Industry Perry Romanowski Alberto Culver 9-Oct OTC Sunscreen Development and Chemistry Craig Bonda Hallstar 16-Oct Polymer Science - Polymer Chemistry, Use of Polymers in Hair and Skin Care TBD BASF or ISP 23-Oct Delivery of Actives and Molecules in Cosmetics TBD BASF 30-Oct The Use of Active Ingredients in Personal Care Anna Gripp DSM 6-Nov Cosmetic Product Manufacturing - How to Take a Formulation from Lab Scale to Manufacturing Scale, What are the Challenges of the Contract Manufacturing Business Gene Frank Raani Corporation 13-Nov Claim Substantiation for Cosmetic and OTC Products for Skin and Hair - Types of Claims, Types of Testing, How to Design Studies Barb Dvoracek Kimberly-Clark

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1

Benedictine University Cosmetic Chemistry Course Topics Date Module Focus Speaker Company

11-Sep

Introduction to Cosmetics - Trends Size of Industry Products

Chemical Classes Raw Materials Used Formulation Types Scott Wenzel Kimberly-Clark

18-Sep

Surfactants - Types of Surfactants Surfactant Chemistry

Formulation of Surfactants Tom Schoenberg

Schoenberg

Consulting Inc

25-Sep

Emulsions - Types of Emulsions Emulsion Theory Formulation of

Emulsions Perry Romanowski Alberto Culver

2-Oct

Formulation Module - What is Formulating How to Formulate

Various Types of Products in the Industry Perry Romanowski Alberto Culver

9-Oct OTC Sunscreen Development and Chemistry Craig Bonda Hallstar

16-Oct

Polymer Science - Polymer Chemistry Use of Polymers in Hair and

Skin Care TBD BASF or ISP

23-Oct Delivery of Actives and Molecules in Cosmetics TBD BASF

30-Oct The Use of Active Ingredients in Personal Care Anna Gripp DSM

6-Nov

Cosmetic Product Manufacturing - How to Take a Formulation from

Lab Scale to Manufacturing Scale What are the Challenges of the

Contract Manufacturing Business Gene Frank Raani Corporation

13-Nov

Claim Substantiation for Cosmetic

and OTC Products for Skin and Hair - Types of Claims Types of

Testing How to Design Studies Barb Dvoracek Kimberly-Clark

2

Who is Scott Wenzel

bullEducational and Work History

ndashMay 1994 - Graduated from UW-LaCrosse with a BS in BiologyChemistry

ndashSept 1994 ndash Tsumura International hires Scott as a Jr Formulation Chemist

ndashDec 1998 ndash Northwest Cosmetic Laboratories hires Scott as RampD Mgr

ndashApril 2002 ndash NuSkin hires Scott as Sr Research Scientist

ndashDec 2004 ndash Kimberly-Clark hires Scott as Sr Research Scientist

ndashAug 2007 ndash Currently Technical Leader for RampD Formulation Team

3

Who is Scott Wenzel

bullSCC Background

ndashMember of SCC since 1994

ndashSept 1997 ndash Treasurer of Twin Cities Chapter of SCC

ndashJan 2003 ndash Founder of the Intermountain West Chapter of SCC

ndashJan 2003 ndash First Chair of the Intermountain West Chapter of SCC

ndashAug 2003 ndash Coordinated first annual Intermountain West Chapter SCC Golf Outing

ndashJan 2004 ndash Serve a 2nd term as Chair of the Intermountain Chapter of SCC

ndashSept 2006 ndash Chair-Elect of Midwest Chapter of SCC

ndashSept 2007 ndash Chair of Midwest Chapter of SCC

4

Society of Cosmetic Chemists

bullDedicated to the advancement of cosmetic science the

Society strives to increase and disseminate scientific

information through meetings and publications

bullPromotes research in cosmetic science and industry and

improves the qualifications of cosmetic scientists

bullFounded in 1945 it now has over 4000 members

bullThere are now 18 chapters with membership from 35 to

1100 members

bullFor further information visit wwwscconlineorg

5

Midwest Chapter of Society of Cosmetic Chemists

bullWas the first chapter formed in 1948

bullToday has almost 400 members

bullChapter holds 7 educational meetingsyear as well as 1-2

social eventsyear in the Chicago area

bullChapter also hosts a vendor supplier day which will occur

in March 2008

bullPublishes a newsletter called SCCoop

bullFor more information visit wwwmidwestsccorg

6

Cosmetic Overview

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 2: 182788984 Formulation Classes and Raw Materials2 Ppt

2

Who is Scott Wenzel

bullEducational and Work History

ndashMay 1994 - Graduated from UW-LaCrosse with a BS in BiologyChemistry

ndashSept 1994 ndash Tsumura International hires Scott as a Jr Formulation Chemist

ndashDec 1998 ndash Northwest Cosmetic Laboratories hires Scott as RampD Mgr

ndashApril 2002 ndash NuSkin hires Scott as Sr Research Scientist

ndashDec 2004 ndash Kimberly-Clark hires Scott as Sr Research Scientist

ndashAug 2007 ndash Currently Technical Leader for RampD Formulation Team

3

Who is Scott Wenzel

bullSCC Background

ndashMember of SCC since 1994

ndashSept 1997 ndash Treasurer of Twin Cities Chapter of SCC

ndashJan 2003 ndash Founder of the Intermountain West Chapter of SCC

ndashJan 2003 ndash First Chair of the Intermountain West Chapter of SCC

ndashAug 2003 ndash Coordinated first annual Intermountain West Chapter SCC Golf Outing

ndashJan 2004 ndash Serve a 2nd term as Chair of the Intermountain Chapter of SCC

ndashSept 2006 ndash Chair-Elect of Midwest Chapter of SCC

ndashSept 2007 ndash Chair of Midwest Chapter of SCC

4

Society of Cosmetic Chemists

bullDedicated to the advancement of cosmetic science the

Society strives to increase and disseminate scientific

information through meetings and publications

bullPromotes research in cosmetic science and industry and

improves the qualifications of cosmetic scientists

bullFounded in 1945 it now has over 4000 members

bullThere are now 18 chapters with membership from 35 to

1100 members

bullFor further information visit wwwscconlineorg

5

Midwest Chapter of Society of Cosmetic Chemists

bullWas the first chapter formed in 1948

bullToday has almost 400 members

bullChapter holds 7 educational meetingsyear as well as 1-2

social eventsyear in the Chicago area

bullChapter also hosts a vendor supplier day which will occur

in March 2008

bullPublishes a newsletter called SCCoop

bullFor more information visit wwwmidwestsccorg

6

Cosmetic Overview

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 3: 182788984 Formulation Classes and Raw Materials2 Ppt

3

Who is Scott Wenzel

bullSCC Background

ndashMember of SCC since 1994

ndashSept 1997 ndash Treasurer of Twin Cities Chapter of SCC

ndashJan 2003 ndash Founder of the Intermountain West Chapter of SCC

ndashJan 2003 ndash First Chair of the Intermountain West Chapter of SCC

ndashAug 2003 ndash Coordinated first annual Intermountain West Chapter SCC Golf Outing

ndashJan 2004 ndash Serve a 2nd term as Chair of the Intermountain Chapter of SCC

ndashSept 2006 ndash Chair-Elect of Midwest Chapter of SCC

ndashSept 2007 ndash Chair of Midwest Chapter of SCC

4

Society of Cosmetic Chemists

bullDedicated to the advancement of cosmetic science the

Society strives to increase and disseminate scientific

information through meetings and publications

bullPromotes research in cosmetic science and industry and

improves the qualifications of cosmetic scientists

bullFounded in 1945 it now has over 4000 members

bullThere are now 18 chapters with membership from 35 to

1100 members

bullFor further information visit wwwscconlineorg

5

Midwest Chapter of Society of Cosmetic Chemists

bullWas the first chapter formed in 1948

bullToday has almost 400 members

bullChapter holds 7 educational meetingsyear as well as 1-2

social eventsyear in the Chicago area

bullChapter also hosts a vendor supplier day which will occur

in March 2008

bullPublishes a newsletter called SCCoop

bullFor more information visit wwwmidwestsccorg

6

Cosmetic Overview

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 4: 182788984 Formulation Classes and Raw Materials2 Ppt

4

Society of Cosmetic Chemists

bullDedicated to the advancement of cosmetic science the

Society strives to increase and disseminate scientific

information through meetings and publications

bullPromotes research in cosmetic science and industry and

improves the qualifications of cosmetic scientists

bullFounded in 1945 it now has over 4000 members

bullThere are now 18 chapters with membership from 35 to

1100 members

bullFor further information visit wwwscconlineorg

5

Midwest Chapter of Society of Cosmetic Chemists

bullWas the first chapter formed in 1948

bullToday has almost 400 members

bullChapter holds 7 educational meetingsyear as well as 1-2

social eventsyear in the Chicago area

bullChapter also hosts a vendor supplier day which will occur

in March 2008

bullPublishes a newsletter called SCCoop

bullFor more information visit wwwmidwestsccorg

6

Cosmetic Overview

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 5: 182788984 Formulation Classes and Raw Materials2 Ppt

5

Midwest Chapter of Society of Cosmetic Chemists

bullWas the first chapter formed in 1948

bullToday has almost 400 members

bullChapter holds 7 educational meetingsyear as well as 1-2

social eventsyear in the Chicago area

bullChapter also hosts a vendor supplier day which will occur

in March 2008

bullPublishes a newsletter called SCCoop

bullFor more information visit wwwmidwestsccorg

6

Cosmetic Overview

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 6: 182788984 Formulation Classes and Raw Materials2 Ppt

6

Cosmetic Overview

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 7: 182788984 Formulation Classes and Raw Materials2 Ppt

7

Overview of Presentation

bull How large is the cosmetic industry

bull What are the trends

bull What types of products are in the market

bull What ingredients are used

bull What types of formulations are utilized

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 8: 182788984 Formulation Classes and Raw Materials2 Ppt

8

Cosmetic Industry

bull Size and Growth

ndash Globally $253 Billion Revenue in 2005 (Euromonitor)

ndash 37 Growth through 2010 $300 Billion

bull Highly Fragmented

ndash Thousands of finished good companies from garage scale to multi-billion dollar corporations

ndash Thousands of raw material suppliers

ndash Low barriers to entry (not capital intensive)

ndash Trend increasing with direct to consumer channels

bull Marketing Intensive

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 9: 182788984 Formulation Classes and Raw Materials2 Ppt

9

Overview of Cosmetics and Toiletries Worldwide Category Size

CAGR to 2011

projected at 30

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 10: 182788984 Formulation Classes and Raw Materials2 Ppt

10

Baby Care

Bath and Show er Products

Deodorants

Hair Care

Color Cosmetics

Mens Grooming Products

Oral Hygiene

Fragrances

Skin Care

Depilatories

Sun Care

17 78

45

186

128

78

94

109

23

11 24

Overview of Cosmetics and Toiletries Breakdown by Sub-Category

Hair Care and Skin Care are biggest subcategories

copyCopyright and database Euromonitor International 2007

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 11: 182788984 Formulation Classes and Raw Materials2 Ppt

11

2006

World

Cosmetics and toiletries

Supermarketshypermarkets 255

Independent food stores 31

Convenience stores 24

Pharmaciesdrugstores 18

Discounters 76

Department stores 126

Specialists 127

Direct sales 129

Outdoor markets 14

Others 36

Overview of Cosmetics and Toiletries ndash Channel

copyCopyright and database Euromonitor International 2007

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 12: 182788984 Formulation Classes and Raw Materials2 Ppt

12

2001 2006

Cosmetics and

World 19637560 26990910

Asia Pacific 4892670 6497130

Australasia 238850 413810

Eastern Europe 923350 1930190

Latin America 2299130 3634290

Africa and Middle East 1424480 1182790

North America 4876200 5590350

Western Europe 4982870 7742350

Overview of Cosmetics and Toiletries ndash Sales by Region

copyCopyright and database Euromonitor International 2007

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 13: 182788984 Formulation Classes and Raw Materials2 Ppt

13

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Demographics

-gtFalling birth rates

-gtAging Populations

-gtAge Compression

-gtWellness

Economic

-gt Non-Essentials

-gt Polarization of Wealth

copyCopyright and database Euromonitor International 2007

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 14: 182788984 Formulation Classes and Raw Materials2 Ppt

14

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Political Activity

-gt Globalization

-gt Regulation

Social Trends

-gtUrbanization

-gt Changing Lifestyles

-gt Nutrition

-gt Celebrity Culture

-gt EnvironmentalEthical

copyCopyright and database Euromonitor International 2007

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 15: 182788984 Formulation Classes and Raw Materials2 Ppt

15

Overview of Cosmetics and Toiletries ndashKey Trends and Influences

Company Activity

-gt Consolidation

-gt Education

-gt Mega-Branding

-gt Cross-Industry Innovation

Technology

-gtEfficacy multi-functionality

-gt New Media

copyCopyright and database Euromonitor International 2007

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 16: 182788984 Formulation Classes and Raw Materials2 Ppt

16

Overview of Cosmetics and Toiletries ndashBaby Care

Gerberrsquos Products

With ldquoSkin Nutrientsrdquo

Baby Spa with

Oatmeal

Earthrsquos Best

Baby Body Care

copyCopyright and database Euromonitor International 2007

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 17: 182788984 Formulation Classes and Raw Materials2 Ppt

17

Overview of Cosmetics and Toiletries ndashBath and Shower

copyCopyright and database Euromonitor International 2007

Vitamins Moisturizers

Minerals

Antibacterial

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 18: 182788984 Formulation Classes and Raw Materials2 Ppt

18

Overview of Cosmetics and Toiletries ndashDeodorants

copyCopyright and database Euromonitor International 2007

Body Sprays Sticks and Roll-On

Unisex Products Split to Gender

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 19: 182788984 Formulation Classes and Raw Materials2 Ppt

19

Overview of Cosmetics and Toiletries ndashHair Care

copyCopyright and database Euromonitor International 2007

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 20: 182788984 Formulation Classes and Raw Materials2 Ppt

20

Overview of Cosmetics and Toiletries ndashColor Cosmetics

copyCopyright and database Euromonitor International 2007

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 21: 182788984 Formulation Classes and Raw Materials2 Ppt

21

Overview of Cosmetics and Toiletries ndashSkin Care

copyCopyright and database Euromonitor International 2007

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 22: 182788984 Formulation Classes and Raw Materials2 Ppt

22

Overview of Cosmetics and Toiletries ndashDepilatories

copyCopyright and database Euromonitor International 2007

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 23: 182788984 Formulation Classes and Raw Materials2 Ppt

23

Overview of Cosmetics and Toiletries ndashSun Care

copyCopyright and database Euromonitor International 2007

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 24: 182788984 Formulation Classes and Raw Materials2 Ppt

24

Cosmetic Industry Jobs

bullTypes of Companies

ndashContract Manufacturers

ndashMulti-level Companies

ndashDirect Sales Companies

ndashRaw Material Vendors

ndashFragrance Suppliers

ndashDistributors

bullScience Related Jobs in these Companies

ndashFormulation Chemist

ndashAnalytical Chemist

ndashQuality Control Specialist

ndashMicrobiologist and Life Scientists

ndashPerfumers

ndashTechnical Sales

ndashScience Related Intellectual Property and Law

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 25: 182788984 Formulation Classes and Raw Materials2 Ppt

25

Classes of Formulations and Raw Material Overview

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 26: 182788984 Formulation Classes and Raw Materials2 Ppt

26

Overview

bull What is a cosmetic and drug

bull What is formulating

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 27: 182788984 Formulation Classes and Raw Materials2 Ppt

27

What is a Cosmetic

bull The Food Drug and Cosmetic Act (FDampC Act) defines cosmetics by their intended use as articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human bodyfor cleansing beautifying promoting attractiveness or altering the appearance [FDampC Act sec 201(i)]

bull Said another wayhellip

bull A substance or preparation intended for placement in contact with any external part of the human body including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it or maintaining it in good condition or perfuming it or protecting it

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 28: 182788984 Formulation Classes and Raw Materials2 Ppt

28

Are All Cosmetics Created Equally

bull The FDampC Act defines drugs by their intended use as (A) articles intended for use in the diagnosis

cure mitigation treatment or prevention of diseaseand (B)

articles (other than food) intended to affect the structure or any function of the body of man

or other animals

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 29: 182788984 Formulation Classes and Raw Materials2 Ppt

29

Formulation Defined

bull The act process or result of formulating or reducing to a formula Websters Revised Unabridged Dictionary (1913)

bull AKA ldquoAdvanced Bakingrdquo or ldquoBucket Chemistryrdquo

+ +

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 30: 182788984 Formulation Classes and Raw Materials2 Ppt

30

Formulation Defined

bull Formulating is a ComplexhellipIterativehellipCombination of Art and Science

Performance

Aesthetics

Stability

Preservative

Efficacy

Scale Up

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 31: 182788984 Formulation Classes and Raw Materials2 Ppt

31

What Ingredients Do We Choose

2006 International Cosmetic Ingredient

Dictionary and Handbook features

bull13000 INCI names recognized in the United

States the European Union (EU) and many

other countries as the labeling names that

MUST be used on cosmetic and personal care

product packages These INCI names are cross-

referenced to 59000 trade names associated

with more than 3000 suppliers from 95

countries

bull15 Sections containing all the critical

information needed to identify INCI labelling

names CAS and EINECS registry numbers

Empirical formulas CIR Index OTC Index EU

Index sources to find additional information

about specific ingredients and much more

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 32: 182788984 Formulation Classes and Raw Materials2 Ppt

32

General Classes of Raw Materials

bull Surfactants

ndash Cleansing agents

ndash Emulsifiers

bull Skin Conditioning Agents

bull Humectants

bull Emollients

bull Occlusive AgentsFilm Formers

bull Rheology Modifiers (Viscosity Increasing Agents)

ndash Aqueous

ndash Nonaqueous

bull Preservatives

bull Chelating Agents

bull Active Ingredients

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 33: 182788984 Formulation Classes and Raw Materials2 Ppt

33

Surfactants

Surfactants ndash Cleansing agents

bull Used for skinhair cleansing purposes In this function surfactants wet body surfaces emulsify or solubilize oils and suspend soil

bull It is characteristic and expected by most consumers that these should contribute foamlather to cleansing products

bull Examples

ndash Sodium Lauryl Sulfate (SLS)

ndash Ammonium Laureth Sulfate (ALES)

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 34: 182788984 Formulation Classes and Raw Materials2 Ppt

34

Surfactants

What is a surfactant

bull A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface

bull How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance

bull Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the ldquoHead amp Tailrdquo approach The elongated hydrophobic end is the tail while the hydrophilic end is the head

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 35: 182788984 Formulation Classes and Raw Materials2 Ppt

35

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface

(2) As the concentration is increased the surfactants aggregate in the solution and form micelles reducing surface tension

Concentration

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)

Surface

Tension

(Nm)

Increasing surfactant concentration does

not result in in a further decrease of

surface tension

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 36: 182788984 Formulation Classes and Raw Materials2 Ppt

36

Surfactants

Surfactants ndash Emulsifying Agents

bull Are employed in cosmetics to prepare emulsions

bull Their efficacy depends on their ability to

ndash Reduce surface tension

ndash Form complex films on the surface of emulsified droplets

ndash Create a repulsive barrier on emulsified droplets to prevent their coalescence

bull Examples

ndash Ceteareth-20

ndash PPG-2 Isoceteth-20 Acetate

ndash Glyceryl Stearate SE

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 37: 182788984 Formulation Classes and Raw Materials2 Ppt

37

General Classification of Emulsifiers

Amphotheric

Emulsifier

Non-ionic Ionic

Anionic Cationic GMS-SE

TEA-Stearate

Sodium

Cetearyl

Sulfate

Cetylpyridinium

Chloride

Distearyldimonium

Chloride

Lecithin

(Phospholipids)

bullCTFA website lists 1893 materials of emulsifiers

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 38: 182788984 Formulation Classes and Raw Materials2 Ppt

38

Non-Ionic Emulsifiers

bull Fatty-alcohol ethoxylates dominate but also includes PEG Glyceryl Sucrose and Polyglyceryl esters ether and in many instances silicone based compounds

ndash Typical alkyl chain for alcohol ethoxylates distributed between C12-18

bull Broad compatibility

bull Inexpensive

bull Generally organized by hydrophilichydrophobic character (HLB)

bull Best stability amp effectiveness is achieved through combinations of emulsifiers

ndash EG Arlacel 165 is a commercial blend of 50 Glyceryl Stearate (HLB 12) and 50 PEG-100 Stearate (HLB 188) allow for a broad range or materials to be emulsified

ndash Achieves smallest droplet size highest stability lowest amount of surfactant

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 39: 182788984 Formulation Classes and Raw Materials2 Ppt

39

Typical Non-Ionic Emulsifiers

bull Glyceryl Stearate

bull PEG-100 Stearate

bull Stearyl Alcohol

bull Cetyl Alcohol

bull Laureth-23

bull Steareth Alcohol

bull CetylPEGPPG 10 Dimethicone

bull Stearic Acid

bull Polyglyceryl 2 Diisostearate

bull PEG 30 Dipolyhydroxystearate

bull Many are more effective as rheology modifiers

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 40: 182788984 Formulation Classes and Raw Materials2 Ppt

40

Anionic

bull Cetyl Phosphate

bull Sodium Dihydroxycetyl Phosphate

bull Sodium Lauroyl Lactylate

bull C10-C30 AlkylAcrylate Crosspolymer (Pemulen TR-2)

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 41: 182788984 Formulation Classes and Raw Materials2 Ppt

41

Cationic

bull Consumer Products Using Cationic Emulsifiers

Dry powdery smooth skin feel is able to mask high lipophilic

content

Distearyldimonium chloride

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 42: 182788984 Formulation Classes and Raw Materials2 Ppt

42

Oil and Water Donrsquot Mixhellip

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 43: 182788984 Formulation Classes and Raw Materials2 Ppt

43

Unless you are a formulator

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 44: 182788984 Formulation Classes and Raw Materials2 Ppt

44

bull Oil and water alone cannot form an emulsion

bull The phases will separate once energy is removed from the system (kinetically unstable)

bull Something needs to be added to stabilize the emulsionhellip

Normal OilWater Interaction

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 45: 182788984 Formulation Classes and Raw Materials2 Ppt

45

Love

Oil + Water 4 Ever

Well maybe a littlehellip

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 46: 182788984 Formulation Classes and Raw Materials2 Ppt

46

Surfactants - Emulsifiers

bull Surfactant = Surface Active Agent

bull A molecule with a polar ldquoheadrdquo group and a non-polar ldquotailrdquo

bull For emulsions these are usually nonionic surfactants although there are others

Polar Non-polar

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 47: 182788984 Formulation Classes and Raw Materials2 Ppt

47

bull Surfactants can have more non-polar character than polar character and vice-versa These represent different HLB values

bull Specific oils need specific surfactant polarnon-polar character to be effectively emulsified

Less polar

(low HLB)

More Polar

(High HLB)

Surfactants - Emulsifiers

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 48: 182788984 Formulation Classes and Raw Materials2 Ppt

48

Examples of matching HLB values to application needs

bull mixing unlike oils together

bull ndashuse surfactants with HLBrsquos of 1 to 3

bull making water-in-oil emulsions

bull ndashuse surfactants with HLBrsquos of 4 to 6

bull wetting powders into oils

bull ndashuse surfactants with HLBrsquos of 7 to 9

bull making self emulsifying oils

bull ndashuse surfactants with HLBrsquos of 7 to 10

bull making oil-in-water emulsions

bull ndashuse surfactant blends with HLBrsquos of 8 to16

bull making detergent solutions

bull ndashuse surfactants with HLBrsquos of 13 to 15

bull for solubilizing oils ( micro-emulsifying ) into water

bull ndashuse surfactant blends with HLBrsquos of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection Uniqema

Presentation to the Midwest Chapter of the Society of Cosmetic Chemists

09 March 2004

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 49: 182788984 Formulation Classes and Raw Materials2 Ppt

49

bull When added to oil and water a surfactant will arrange itself such that itrsquos non-polar tail is within the oil and its polar heads are exposed to the water

bull Spherical arrangement of surfactant is known as a micelle

Polar heads

Oil Droplet

Non-polar tails

Surfactants - Emulsifiers

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 50: 182788984 Formulation Classes and Raw Materials2 Ppt

50

Emulsion

bull An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other

bull Continuous phase and dispersed phase

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 51: 182788984 Formulation Classes and Raw Materials2 Ppt

51

Skin Moisturization

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 52: 182788984 Formulation Classes and Raw Materials2 Ppt

52

Moisturizers Are Everywhere

Lotions and Creams Body Washes Hand Sanitizers

Sunscreens Lip Balms

Hand Soaps

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 53: 182788984 Formulation Classes and Raw Materials2 Ppt

53

Too

Wet

Too

Dry

Just

Right

bull Skin maceration

bull Loss of barrier function

bull Reduced rate of barrier repair

bull Corneocyte swelling

bull Wrinkling

bull Skin flaking

bull Loss of skin barrier

bull Loss of skin elasticity

bull Skin cracksfissures

bull Painful andor pruritic skin

bull Skin roughness

The importance of skin moisture

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 54: 182788984 Formulation Classes and Raw Materials2 Ppt

54

Factors that effect skin moisture

bull Skinrsquos ability to control water diffusion (Skin Barrier Function)

bull Skinrsquos ability to retain water (Natural Moisturizing Factors)

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 55: 182788984 Formulation Classes and Raw Materials2 Ppt

55

How Do Moisturizers Work

bull Enhancing barrier function

bull This is generally done with skin conditioning agents

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 56: 182788984 Formulation Classes and Raw Materials2 Ppt

56

Skin Conditioning Agents

Emollient

bull Help maintain the soft smooth and pliable appearance of skin

bull They function by their ability to remain on the skin surface or in stratum corneum

bull Act as lubricants to reduce flaking and to improve the skinrsquos appearance

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 57: 182788984 Formulation Classes and Raw Materials2 Ppt

57

Skin Conditioning Agents

Emollients can be

bull Hydrocarbons ndash Mineral Oil

bull Natural Oils ndash Jojoba Oil

bull Esters ndash Isopropyl Palmitate Myristyl Myristate

bull Triglycerides ndash CaprylicCapric Triglyceride

bull Silicones ndash Cyclomethicone

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 58: 182788984 Formulation Classes and Raw Materials2 Ppt

58

Skin Conditioning Agents

Occlusive

bull Retard the evaporation of water from the skin surface and therefore increase the water content of the skin

bull Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin ie Hydrocortisone Creams

bull Examples

ndash Petrolatum

ndash Beeswax

ndash Paraffin Wax

ndash Dimethicone

ndash Shea Butter

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 59: 182788984 Formulation Classes and Raw Materials2 Ppt

59

= Lipids

= Corneocyte (cell remnant)

The stratum corneum is composed of corneocytes (bricks)

embedded within a lipid matrix (mortar)

Skin Barrier The Brick and Mortar Model

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 60: 182788984 Formulation Classes and Raw Materials2 Ppt

60

Normal Skin w Normal Barrier

H2O H2O

Inflammation

H2O

H2O

H2O

Dry Skin w Damaged Barrier

Vs

Skin lipids help maintain normal barrier

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 61: 182788984 Formulation Classes and Raw Materials2 Ppt

61

Lipids Repair Barrier Damage

Irritant H2O

H2O

Dry Skin w Damaged Barrier

H2O H2O

H2O

Apply Lipids

Barrier Function Repair

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 62: 182788984 Formulation Classes and Raw Materials2 Ppt

62

Formulation Considerations

bull Most are water insoluble so must be delivered either in the oil phase of an emulsion system or in an anhydrous system

bull Too much of a barrier material can result in a formulation that feels greasy waxy or heavy

bull Fatty materials can go rancid over time preservatives should be used to delay or prevent this

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 63: 182788984 Formulation Classes and Raw Materials2 Ppt

63

How Do Moisturizers Work

bull Enhancing water absorption and retention

bull This is generally done with humectants

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 64: 182788984 Formulation Classes and Raw Materials2 Ppt

64

Skin Conditioning Agents

Humectant

bull Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin

bull Examples Glycerin Propylene Glycol

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 65: 182788984 Formulation Classes and Raw Materials2 Ppt

65

Stratum corneum (dried and cracked)

Relief

Humectants in Formulations

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 66: 182788984 Formulation Classes and Raw Materials2 Ppt

66

Raw Materials that Enhance Moisture Retention

bull Glycerin

bull Alpha-hydroxy acids

bull Urea

bull Pyrrolidone Carboxylic Acid (PCA)

bull Glycols (propylene butylene)

bull Amino acids

Glycerin is by far the most commonly seen

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 67: 182788984 Formulation Classes and Raw Materials2 Ppt

67

Formulation Considerations

bull Most humectants are water-soluble and can easily be incorporated in water-based formulations Use in anhydrous formulations is limited

bull Many formulations (especially washes soaps or hand sanitizers) that state ldquowith moisturizersrdquo on the label contain glycerin or another humectant

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 68: 182788984 Formulation Classes and Raw Materials2 Ppt

68

Skin Benefits Attributable to Moisturizers

bull Decrease dry flaky appearance

bull Reduce the incidence of fine lines and fissures

bull Increase skin elasticity and suppleness

bull Provide relief from itching or pain

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 69: 182788984 Formulation Classes and Raw Materials2 Ppt

69 Shai A et al Eds Handbook of Cosmetic Skin Care (2001)

Moisturizers Result in More Elasticity

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 70: 182788984 Formulation Classes and Raw Materials2 Ppt

70

Moisturizing Formulas on the Market

bull Water Glycerin Stearyl Alcohol Mineral Oil Glyceryl Stearate Myristyl Myristate PEG 100 Stearate C12 - 15 Alkyl Benzoate Dimethicone Cetyl Alcohol Stearic Acid Phenoxyethanol Fragrance Carbomer Methylparaben Potassium Hydroxide Ethylparaben Disodium EDTA Propylparaben Butylparaben Xanthan gum Microcrystalline Wax BHT Butylene Glycol Aloe Barbadensis (Leaf Extract) Calendula Officinalis (Calendula) Flower Extract Camellia Oleifera Leaf Extract Cucumis Sativus (Cucumber) Fruit Extract Retinyl Palmitate Tocopheryl acetate

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 71: 182788984 Formulation Classes and Raw Materials2 Ppt

71

Moisturizing Formulations

bull Active Ingredients Dimethicone

bull Inactive Ingredients Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oat Flour (Avena Sativa) Benzyl Alcohol Sodium Chloride

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 72: 182788984 Formulation Classes and Raw Materials2 Ppt

72

Additional Ingredients

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 73: 182788984 Formulation Classes and Raw Materials2 Ppt

73

Film Formers

bull Materials which upon drying produce a continuous film on skin hair or nails

bull Uniform films can enhance the efficacy of an ldquoactiverdquo such as a sunscreen skin protectant or moisturizer

bull Can be used to improve the wash off or removal of an ldquoactiverdquo ingredient from the skin surface

bull Examples

ndash PVP

ndash PVA

ndash Ethylene Vinyl Acetate Copolymer

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 74: 182788984 Formulation Classes and Raw Materials2 Ppt

74

Viscosity Increasing Agents

Aqueous

bull Are used to thicken the aqueous portions of cosmetic products

bull Ability to thicken is related to the water solubility or hydrophilic nature

bull Examples of aqueous thickeners

ndash Salts ndash Sodium Chloride Ammonium Chloride

ndash Cellulose Type ndash HEC HPMC CMC

ndash Gums ndash Guar Xanthan Acacia

ndash Modified Starch ndash Potato Tapioca

ndash Polymers - Pemulen TR-1 Carbomer

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 75: 182788984 Formulation Classes and Raw Materials2 Ppt

75

Polysaccharide Thickening Mechanism

bull Formation of Colloidal Network

ndash High yield value

ndash Excellent pH and electrolyte tolerance

bull Effective across a broad pH range

bull Excellent temperature and electrolyte stability

bull Good solubility in hot and cold water

bull Rheology may be too stiff for some applications

bull Synergy with other rheology modifiers (eg clays)

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 76: 182788984 Formulation Classes and Raw Materials2 Ppt

76

Clays

bull Magnesium Aluminum Silicate (eg VEEGUMcopy)

bull Smectite clay platelets

ndash Hydrates in water

ndash Forms necessary colloidal structure ldquohouse of cardsrdquo

bull Positively charged edges of platelets interact with negatively charged faces to build structure

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 77: 182788984 Formulation Classes and Raw Materials2 Ppt

77

Clay Platelets

bull Negatively charged platelet faces and positively charged edges

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 78: 182788984 Formulation Classes and Raw Materials2 Ppt

78

Forms Structure

bull When hydrated clay assembles a 3D structure

bull Traps solids oils and gasses

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 79: 182788984 Formulation Classes and Raw Materials2 Ppt

79

Viscosity Increasing Agents-Anhydrous

Nonaqueous

bull Used to thicken the lipid portions of cosmetic products

bull Ability to thicken is the result of their water insolubility and compatability with lipids

bull Examples of aqueous thickeners

ndash Waxes ndash Beeswax Microcrystalline Wax

ndash Alcohols ndash Cetyl Stearyl

ndash Butters ndash Shea Butter

ndash Hydrogenated Oils

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 80: 182788984 Formulation Classes and Raw Materials2 Ppt

80

Preservatives

bull Ingredients which prevent or retard microbial growth and thus protect products from spoilage

bull Use is required to prevent rancidity appearanceodor changes to the product caused by microorganisms

bull Protects activityfunctionality of the product

bull Protects from inadvertent contamination by consumer during use or production

bull The functionality of many classes is determined by the pH conditions of manufacturing and order of addition To prevent microbial growth in a product

bull Examples

ndash DMDM Hydantoin

ndash Parabens

ndash Phenoxyethanol

ndash Quaterniary Amines

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 81: 182788984 Formulation Classes and Raw Materials2 Ppt

81

Types of preservation

bull Radiation

bull Heat or cold

bull Packaging

bull Chemical and Natural Preservatives

ndash Water activity reducers

ndash Antioxidants

ndash Chelators

ndash pH adjusters

ndash Antimicrobials

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 82: 182788984 Formulation Classes and Raw Materials2 Ppt

82

Brief History of Preservatives

bull 3000BC Salt honey and oils used to preserve mummies in Egypt

bull BC Salt used to preserve meats around the world

bull 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer

bull 1875 Benzoic acidrsquos preservative properties are discovered Gum benzoin had been discovered in 1556 by Nostradamus

bull 1876 Refrigerators invented ndash cold known to help preserve

bull 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them ndash Pasteurization

bull 1924 Parabens introduced into cosmetics for preservation

bull 1939 Sorbic acids preservative properties are discovered

bull 1945 After WWII new chemistries develop new needs for preservatives Synthetic preservatives flourish

bull 1970s Regulations are tightened on cosmetics around the world affecting preservative choices

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 83: 182788984 Formulation Classes and Raw Materials2 Ppt

83

Microbial Paradise

bull Cosmetics contain food numerous food sources for microbes water proteins trace metals carbon amino acids

bull pH of products can enhance microbial growth

ndash Most bacteria flourish in pHs between 65-75 but actual range of growth is 45-90

ndash Yeasts abound around 40-65 but can be seen as low as 15 and up to 96

ndash Molds enjoy a pH between 45 and 68 but can found between 12 (A niger) and 11

bull High water activity is preferred

ndash Most bacteria need activity above 090 S aureus can go to 084

ndash Most yeasts prefer above 087 osmophilic yeasts can survive down to 060

ndash Most molds are prefer water activity above 060

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 84: 182788984 Formulation Classes and Raw Materials2 Ppt

84

Things to Consider

bull What are we concerned with as formulators

ndash Gram negative bacteria

ndash Gram positive bacteria

ndash Yeastmold

bull Best preservative system is one that is broad a broad spectrum blend

ndash Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens

ndash Optiphenreg Plus (ISP) is a blend of phenoxyethanol caprylyl glycol and sorbic acid

bull Use preservative boosting techniques

ndash Chelating agents such as EDTA

ndash pH modification with acidsbases

ndash Water activity reducers (glycols

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 85: 182788984 Formulation Classes and Raw Materials2 Ppt

85

CTFArsquos 28-Day Micro Challenge

bull Inoculum consists of Escherichia coli (G-) Enterobacter cloacae (G-) Pseudomonas aeruginosa (G-) Burkholderia cepacia (G-) Staphylococcus aureus (G+) Candida albicans (Y) and Aspergillus niger (M)

bull All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFUmL

bull Colonies are counted at 1 7 14 21 and 28 days

bull The preservative is effective if there is

ndash Bacteria at least a 999 reduction within 7 days following each challenge and no increase for the duration of test period and

ndash Yeast and Mold at least a 90 reduction within 7 days following each challenge and no increase for the duration of the test period

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 86: 182788984 Formulation Classes and Raw Materials2 Ppt

86

Chelating Agents (Sequestrants)

bull Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products

bull At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients

bull Chelation of ions such as iron or copper helps retard oxidative deterioration of finished products

bull Chelating agents are used to help boost preservative efficacy in cosmetic formulations

bull Examples

ndash Tetrasodium EDTA

ndash Disodium EDTA

ndash Gluconic Acid

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 87: 182788984 Formulation Classes and Raw Materials2 Ppt

87

Active Ingredients

bull Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used

bull Incorporated to alter the structure and function of the skin

bull Within cosmetics over-the-counter products (rash creams sunscreens) are regulated by the FDA under an appropriate monograph

bull Are all products which change the structure or function of skin regulated by the FDA No

bull Is there consistent agreement as to what it means to change the function amp structure of skin No

bull Claim language is the fine line to distinguish cosmetic from a drug

ndash Cosmetics smoothes soothes moisturizes plumps etc

ndash Drug cures treats prevents etc

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 88: 182788984 Formulation Classes and Raw Materials2 Ppt

88

Skin Protectants

bull OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli and may help provide relief to such surfaces

bull Examples

ndash Allantoin

ndash Dimethicone

ndash Petrolatum

ndash Zinc Oxide

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 89: 182788984 Formulation Classes and Raw Materials2 Ppt

89

Other Examples of Active Ingredients

bull OTC Regulated Cosmetics ndash Sunscreens

ndash Rash Creams

ndash Anti-Puritic (Itch

ndash Anti-Dandruff

ndash Anti-Perspirants

ndash External Analgesics (Pain Reduction)

ndash Hand Sanitizers

bull Non-Regulated Products with ldquoActivesrdquo ndash Anti-wrinkle

ndash Anti-cellulite

ndash Stretch marks

ndash Skin Lighteners (US)

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 90: 182788984 Formulation Classes and Raw Materials2 Ppt

90

Fragrance Colorants Aesthetic Enhancers and Label Ingredients

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 91: 182788984 Formulation Classes and Raw Materials2 Ppt

91

Overview

bull Why are they used in formulations

bull Classesfunctions of raw materials

ndash Definitions

ndash Examples of some raw materials in each class

bull Product types in the industry

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 92: 182788984 Formulation Classes and Raw Materials2 Ppt

92

Why are they used in formulations

bull Additives can be

ndash Functional

bull Deliver an end benefit

bull If used in low quantities functional ingredients enhance appeal

ndash Enhance appeal

bull Enhance the five senses of the consumer (sight smell touch taste hearing)

bull Create a story and also be functional

ndash Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 93: 182788984 Formulation Classes and Raw Materials2 Ppt

93

General Classes of Raw Materials

bull Fragrance

ndash Fragrance blends

ndash Essential Oils

ndash Extracts or Waters

bull Flavor

bull Colorants

ndash Dyes

ndash Pigments

ndash Natural colorants

bull Marketing Ingredients

ndash Extracts

ndash Moisturizers

ndash Vitamins

ndash Antioxidants

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 94: 182788984 Formulation Classes and Raw Materials2 Ppt

94

General Classes of Raw Materials

bull Aesthetic Enhancers

ndash Visual

bull Beads

bull Glitter

bull Swirls

bull Opacifiers or pealizing agents

ndash Sensory

bull Warming

bull Cooling

bull Tactile

ndash Powdery finish

bull Exfolliants

ndash Natural

ndash Synthetic

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 95: 182788984 Formulation Classes and Raw Materials2 Ppt

95

Aroma Compounds

bull Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors

bull Types of aroma compounds

ndash Fragrance

bull A mixture of fragrant essential oils aroma compounds solvents and fixatives

bull Can be extremely complex and contain a top note (perceive immediately upon application) middle note (heart of the fragrance) and base note (perceived after dry down)

ndash Essential Oils

bull Hydrophobic portion of a steam distillate

bull Large interest due to the popularity of aromatherapy

bull Examples are Lavender Oil Peppermint Oil

ndash Hydrosols

bull Aqueous phase of a steam distillate and often referred to as essential water floral water or herbal distillate

bull Example are Rose Water Orange Water

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 96: 182788984 Formulation Classes and Raw Materials2 Ppt

96

Flavorant

bull A substance added to impart a pleasant taste to the final formulations

bull Product Examples

ndash Toothpaste

ndash Mouthwash

ndash Lip Balm

ndash Adult novelty products

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 97: 182788984 Formulation Classes and Raw Materials2 Ppt

97

Colorants

bull Materials which impart a visual color to a finished product

bull Types of colorants

ndash Dyes

bull Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially

bull Examples are FDampC Yellow No 5 and DampC Orange No 4

ndash Pigments

bull Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light

bull Examples are FDampC Yellow No 5 Aluminum Lake and DampC Orange No 4 Aluminum lake

ndash Natural

bull Examples are Walnut Extract and Beet Extract

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 98: 182788984 Formulation Classes and Raw Materials2 Ppt

98

Marketing Ingredients

bull Materials which do not add to the end benefit of the product but help to create the product story and reason to believe

bull Generally these are added in very small amounts

bull Examples

ndash Extracts

bull Helianthus Annuus (Sunflower) Extract

ndash Moisturizers

bull Jojoba oil Aloe

ndash Vitamins

bull Vitamin A Vitamin E Vitamin C

ndash Antioxidants

bull Green Tea Extract Vitamin C

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 99: 182788984 Formulation Classes and Raw Materials2 Ppt

99

Aesthetic Enhancers - Visual

bull Materials and or effects that are added to formulations to entice the consumer buy by creating a ldquowowrdquo for the eyes

bull Examples

ndash Beads

bull Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins oils)

ndash Glitter or iridescent pigments

bull Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine

ndash Swirls

bull Can be layers of two separate products or an internal swirl (alternate benefits)

ndash Opacifiers or pearlizing agents

bull Suspended fatty acids powders or other to create a white or luminescent appearance to the product

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 100: 182788984 Formulation Classes and Raw Materials2 Ppt

100

Aesthetic Enhancers - Sensory

bull Materials added to formulations to stimulate the senses or elicit a response from touch

bull Examples

ndash Warming Agents

bull Generally warm due to heat of hydration

ndash Examples would be glycols magnesium chloride calcium chloride

ndash Cooling Agents

bull Due to volatile evaporation or from a neurosensory response

ndash Examples would be ethanol menthol camphor

ndash Tactile Agents

bull Examples would be powders or silicones to elicit a smooth powdery finish on the skin

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 101: 182788984 Formulation Classes and Raw Materials2 Ppt

101

Exfoliants

bull Materials added to formulations aimed at improving skins appearance by removing dead skin cells from the surface of the skin

bull Examples

ndash Physical

bull Synthetic ndash Polyethylene beads

bull Natural ndash Walnut shells

ndash Rice bran

bull Chemical ndash Alpha Hydroxy Acids (AHArsquos) such as Glycolic Acid Lactic Acid Citric Acid

ndash Beta Hydroxy Acids (BHArsquos) such as Salicylic Acid

ndash Polyhydroxy Acids (PHArsquos) such as Gluconolactone Lactobionic Acid

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 102: 182788984 Formulation Classes and Raw Materials2 Ppt

102

Industry Examples

Warming Facial

Cleanser (Biore)

Suspended Antibacterial

Beads (BampBW)

Enriched with Aloe

amp Vitamin E (JampJ)

Suspended Exfoliant

Apricot Shells (St Ives)

Lavender

Aromatherapy Pigments for color transfer

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 103: 182788984 Formulation Classes and Raw Materials2 Ppt

103

Formulation Systems

bull Solutions

bull Oil Based SolutionsAnhydrous

bull Water Based Surfactant Solutions

bull Emulsions

bull Suspensions

bull Powders

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 104: 182788984 Formulation Classes and Raw Materials2 Ppt

104

Solutions

bull Homogeneous mixture of two or more substances

bull Examples

ndash Astringents (Hydro-alcoholic)

ndash Anti-septicmicrobial Hand Gels

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 105: 182788984 Formulation Classes and Raw Materials2 Ppt

105

Anhydrous Formulations

bull Systems which do not contain water

bull Contains mostly hydrophobiclipophilic ingredients

ndash Examples Ointments Lip balmsticks Vaseline

bull Advantages Lipophilic material has direct contact with the skin best film formation and film is not water dispersible (water resistantproof) ease of preservation

bull Disadvantage Poor aesthetics and more costly

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 106: 182788984 Formulation Classes and Raw Materials2 Ppt

106

Foaming surfactant systems

bull Dispersion of hydrophilic surfactants in water (Micellular Surfactant Solutions)

bull Examples

ndash Shampoos

ndash Baby Washes and Bath

ndash Liquid Hand Soaps

ndash Shower Gels

ndash Wet Wipe Solutions

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 107: 182788984 Formulation Classes and Raw Materials2 Ppt

107

Examples of Cleansing Products

Body Wash

Baby Wash

Shower Gel

Bubble Bath

Bubble Bath

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 108: 182788984 Formulation Classes and Raw Materials2 Ppt

108

Emulsions

bull An emulsion is a two phase system consisting of two completely immiscible liquids one of which is dispersed in the other

bull Many types of Emulsions

ndash Oil-in-Water (OW)

ndash Water-in-Oil (WO)

ndash Multiple emulsions (OWO WOW)

bull The majority of Skin Care Products are emulsions

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 109: 182788984 Formulation Classes and Raw Materials2 Ppt

109

Oil-in-Water Emulsions

bull Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (OW)

bull Advantages Typically have better Aesthetics easier to formulate greater choice of emulsifiers amp lower cost

bull Disadvantage Typically does not provide substantivity water proofing and film formation

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 110: 182788984 Formulation Classes and Raw Materials2 Ppt

110

Oil in Water Emulsion

bull The surfactant maintains the small droplet size of the oil keeps the droplets from aggregating (steric hinderance) and the surfactantoil complex is soluble in the water

bull This is known as an oil in water emulsion (OW)

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 111: 182788984 Formulation Classes and Raw Materials2 Ppt

111

Example Products

bull StriVectin-SD Wrinkle and Stretch Mark Cream ($135)

Water (Aqua) C12-15 Benzoate Sesamum Indicum Seed Oil (Sesame) CaprylicCapricTriglyceride Prunus Amygdalus Dulcis Oil (Sweet Almond) Cetearyl Olivate Sorbitan Olivate Striadril Complex (see product details for ingredients list) Glycerin Glyceryl Stearate and PEG-100 Stearate PPG 12SMDI Copolymer Stearic Acid Theobroma Cacao Seed Butter (Cocoa) Butyrospermum Parkii (Shea Butter) Tocopheryl Acetate Mangifera Indica (Mango) Mentha Piperita Oil (Peppermint) Methylparaben Xanthan Gum Triethanolamine Butylparaben Ethylparaben Disodium EDTA Propylparaben Retinyl Palmitate Tetrahexyldecyl Ascorbate

Active Ingredients 4 Octyl Salicylate 2 Avobenzone 1 Phenylbenzimidazole Sulfonic Acid 1 Octocrylene Inactive Ingredients Water Glycerin Dimethicone Niacinamide (Vitamin B3) Isopropyl Isostearate Polyacrylamide Triethanolamine Titanium Dioxide C13-14 Isoparaffin Cetearyl Glucoside PTFE Panthenol (Pro-Vitamin B5) Tocopheryl Acetate (Vitamin E) Stearyl Alcohol Behenyl Alcohol Cetyl Alcohol Sucrose Polycottonseedate Benzyl Alcohol Dimethiconol Carbomer Methylparaben Ethylparaben Propylparaben PEG 100 Stearate Disodium EDTA Laureth-7 Stearic Acid

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 112: 182788984 Formulation Classes and Raw Materials2 Ppt

112

Example Products

bull Aveeno Baby Soothing Relief Moisture Cream Fragrance Free

Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol Dimethicone Avena Sativa (oat) Kernel Flour Carbomer Ceteareth 6 Ethylparaben Sodium Citrate Stearyl Alcohol Propylparaben Methylparaben Sodium Hydroxide Tetrasodium EDTA Benzalkonium Chloride Citric Acid Butylparaben Butylene Glycol Hydrolyzed Milk Protein PEG 25 Soy Sterol Benzaldehyde Hydrolyzed Oats Hydroylzed Soy Protein

Isobutylparaben Phenoxyethanol Ethyl Alcohol

bull Aveeno Foot Cream Intense Relief Water Glycerin Petrolatum Mineral Oil Cetyl Alcohol

Dimethicone Avena Sativa (oat) Kernel Flour Butyrospermum Parkii (Shea Butter) Extract Mentha Piperita (Peppermint) Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Salicylic Acid Menthyl Lactate PEG 25 Soy Sterol Carbomer Ceteareth 6 Stearyl Alcohol Tetrasodium EDTA Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben C12-16 Alkyl Hydroxyethyl Ethylcellulose Sodium Citrate Benzalkonium Chloride Citric Acid Sodium Hydroxide

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 113: 182788984 Formulation Classes and Raw Materials2 Ppt

113

Water-in Oil Emulsions

bull Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (WO)

bull Advantages Oil phase has direct contact with the skin better film formation and film is less water dispersible and continuous (water resistant and provides best ldquoprotectionrdquo)

bull Disadvantage Poor aesthetics and more costly

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 114: 182788984 Formulation Classes and Raw Materials2 Ppt

114

bull The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase

bull This is known as a water in oil emulsion (WO)

Water-in-Oil Emulsion

115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

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115

WO Emulsions- Product Examples

Active Ingredients Ointment contains Dimethicone 1 (diaper rash

cream) Zinc Oxide 10 (diaper rash cream)

Inactive Ingredients Aloe Barbadensis Extract Benzyl Alcohol

Coconut Oil Cod Liver Oil (contains vitamin a amp vitamin d)

Fragrance Glyceryl Oleate Light Mineral Oil Ozokerite Paraffin

Propylene Glycol Sorbitol Synthetic Beeswax Water

Active Ingredients Zinc Oxide (10)

Inactive Ingredients Water Mineral Oil Propylene Glycol

Dioctanoate Methyl Glucose Dioleate Titanium Dioxide PEG 45

Docecyl Glycol Copolymer Glycerin Ceresin Ethyl Linoleate Shea

Butter PEG 8 Panthenol Potassium Sorbate Fragrance

Magnesium Sulfate Methylparaben Caprylyl Glycol

Propylparaben Sodium Polyacrylate

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 116: 182788984 Formulation Classes and Raw Materials2 Ppt

116

Water-in-Oil Product Example

Philosophy hope in a tube eye and lip firming cream

bull Water (aqua) Squalane Mineral Oil Glycerin Isocetyl Stearoyl Stearate Petrolatum Butylene Glycol Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Ceresin Polyethylene Microcrystalline Wax Magnesium Sulfate PhytosterylOctyldodecylLauroyl Glutamate Dipalmitoyl Hydroxyproline Tocopheryl Acetate Polysorbate 80 Bisabolol Potassium Ascorbyl Tocopheryl Phosphate Iron Oxide (CI 77492 CI 77491 and CI77499) Methylparaben Diazolidinyl Urea Ethylparaben Tetrasodium EDTA

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 117: 182788984 Formulation Classes and Raw Materials2 Ppt

117

Multiple Emulsions

bull Emulsions formed when a WO emulsion is emulsified in water or when an OW emulsion is emusified in oil

bull Advantages Good aesthetics and can provide protection of actives within the emulsion

bull Disadvantage Can be difficult to stabilize

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 118: 182788984 Formulation Classes and Raw Materials2 Ppt

118

Emulsifying emulsions

bull With the addition of certain surfactants an oil in water emulsion can be emulsified within an external oil phase

bull This is known as an oil in water in oil (OWO) emulsion

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 119: 182788984 Formulation Classes and Raw Materials2 Ppt

119

bull With the addition of certain surfactants a water in oil emulsion can be emulsified within an external water phase

bull This is known as a water in oil in water (WOW) emulsion

Emulsifying Emulsions

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 120: 182788984 Formulation Classes and Raw Materials2 Ppt

120

Suspensions

bull A dispersion of solid particles in a liquid medium

bull Examples

ndash Anti-acids

ndash Calamine Lotion (ZnOFeO in Water)

ndash Antiperspirants (Al salts in Silicone)

ndash Lipsticks (Pigments in Castor Oil and Waxes)

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 121: 182788984 Formulation Classes and Raw Materials2 Ppt

121

Powders

bull Dry solids composed of numerous fine particles

bull Generally used to absorb moisture and or deliver active ingredients to the skin

bull Examples

ndash Baby Powder

ndash Powder Make-ups

ndash Pressed Powders

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 122: 182788984 Formulation Classes and Raw Materials2 Ppt

122

Conclusions

bull Cosmetic industry is extremely large and continues to grow yearly

bull Multiple trends shape the industry and affect consumer buying intent

bull Multiple product types exist and changes occur due to consumer preference and technology shifts

bull Vast number of ingredients in the industry each with unique attributes and functionality

bull Numerous formulations are used as delivery vehicles in the industry

123

QUESTIONS

Page 123: 182788984 Formulation Classes and Raw Materials2 Ppt

123

QUESTIONS