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I. Product Design Considerations
• Customer Needs• Heals dry skin
• Prevents dry skin
• Non-greasy
• Fast absorbing
• Non-irritating
• Non-scented or Scented
• Contains sun screen
• Prevent further aging of the skin
• Long lasting
Product Design Considerations
• Different Types of Lotion• For Dry Skin
• For Extra Dry Skin
• For Sensative Skin
• Manufacturers• Bath & Body Works
• Suave
• Keri
• Bristol Meyer Squibb
• Clairol
Product Design Considerations
• Product Specifications• Shelf life • Duration• Consistency• Viscous properties• Fragrance• Color• Absorption • Delivery systems of alpha hydroxide, sunscreen,
moisturizing agents
II. Components and CompositionCommon Components Present in Different Brands of Moisturing Lotion*
Suave Bath & Body Bristol The Andrew Body Benefits
Works Meyers Jergens Co.
Water X X X X X
Glycerin X X X X X
(Tetra, Tri, or Di-) sodium EDTA X X X X
Dimethicone X X X X X
Carbomer X X X
Tocopheryl Acetate (Vitamin E) X X X
Aloe gel X X X
Petrolatum X X X X
Glyceryl Stearate X X
Sodium Hydroxide X X
Methylparaben X X X
DM DM Hydantoin X X
Benzyl Alcohol X X
Magnesium Aluminum Silicate X X
Propylparaben X X
Mineral Oil X
Isopropyl palmitate X X
Cetyl Alcohol X X X
Cetearyl Alcohol X X
Ceteareth-20 X X
* Components present in only 1 of the 5 lotions are not listed here.
Approximate Composition of a Lotion Patented by The Andrew Jergens Company (U.S. Patent# 6,017,548)
Chart # Components Approx. % Weight
1 Water 93.2
2 Glycerin 2.4
3 Dimethyl Distearyl Ammonium Chloride 1
4 Petrolatum 0.8
5 Lactic Acid 0.6
6 Isopropyl palmitate 0.6
7 Cetyl Alcohol 0.5
8 Glycolic Acid 0.4
9 Dimethicone 0.3
10 Ammonium Hydroxide 0.2
11 Methylparaben 0.02
12 Propylparaben 0.008
III. Colloids and Surface Interactions
• Functions of colloids in Moisturizing Lotion• Diluent
• Humectant
• Smoothing aid
• Emollient
• Surfactant
Component Basic Function
Water diluentGlycerin humectantDimethicone * emollient, smoothing aidPetrolatum * occlusive emollientDisodium EDTA chelating agentCarbomer * thickening agent, emulsifying agentQuaternium-15 * cationic surfactant, cationic emulsifierCetyl Alcohol * emollient, emulsion modifier, coupling agentTocopheryl Acetate (Vitamin E) * nutrientSteareth-2 * emulsifier, wetting agentAloe gel nutrientBenzyl Alcohol antimicrobialLaureth-23 * emulsifier, wetting agentMagnesium Aluminum Silicate thickening agentSodium Hydroxide alkalizer, pH adjuster* = "colloidal" sized molecules
KERI FRAGRANCE FREE LOTION
Liquid/ Liquid Emulsion
• An emulsion is formed when a mixture of two immiscible liquids are separated by a surfactant molecule.• Oil-in-Water (O/W)
• Water-in-Oil (W/O)
Phase Inversion of Emulsion
• Inversion from W/O to O/W• Variables which lead to phase inversion
• Temperature – Ethoxylate emulsifiers
• Surfactant composition – Hydrophilic emulsifier concentration
• Water concentration – Andrew Jergens Co.
Effect of Amphiphiles on Delivery to the Skin
• Cationic Surfactants• Effect of Temperature and Salt on micelle stability
• Effect of Temperature on delivery
• Pemulen® Polymeric emulsifiers • Triggered release mechanism upon contact with
electrical charge of skin
IV. Product Attributes
• Shelf Life– Emulsion stability is what determines the product’s shelf
like– If the emulsion becomes unstable the lotion will separate– Adjusting the hyrophilic and lipophile balance of the
emulsifier achieves the emulsions stability– The emulsions are thermodynamically unstable due to
its positive interfacial energy– When the emulsion tries to reach it thermodynamic
equilibrium it causes the emulsion to break up back to its component phase
Product Attributes
• Shelf Life– The delay of the component break up can be accomplished
by adding specific mixed emulsions compiled of non-ionic and ionic surfactants and combined with fatty amphiphiles
• Examples can be found in Table 3
– Previously blended emulsifying wax into the the formulation can also help prevent the decay of the emulsions
• Examples can be found in Table 4
Product AttributesTable 3Fatty amphiphiles Surfactants
Cetostearyl alcohol Sodium lauryl sulphateCetyl alcohol CetrimideStearyl alcohol Cetomacrogol 1000Glyceryl monostearate PEG 1000 monostearateStearic acid Triethanolamine stearatePhosphatidylcholine Sodium stearate
Table 4Emulsifying wax Component
Emulsifying wax BP Cetostearyl alcohol, sodium lauryl sulphateEmulsifying wax USNF Cetyl alcohol, polysorbateCationic emulsifying was BPC Cetostearyl alcohol, cetrimideGlyceryl monostearate S.E. Glyceryl monostearate, sodium stearateCetomacrogol emulsifying wax BPC Cetostearyl alcohol, cetomacrogol 1000Polawax Cetyl alcohol, non-ionic surfactant
Product Attributes
• Shelf Life– The gel network theory of emulsion stability is
why both emulsifiers and mixed wax help the shelf life period
– The emulsifiers stabilize the oil droplets by the formation of an interfacial film
Product Attributes
• Consistency– It is related to swelling properties and concentration of
the α-crystalline gel phase– When the α-crystalline form is in presence of very
small quantities of ionic surfactants and a fatty aclohol and is dispersed in water the amount of swelling increases
– This leads to the swelling of the α-crystalline gel phase– The water is in between the bilayers of the gel phase
and when it swells the volume ratio of dispersed phase to the free continuous phase water increases
Product Attributes
• Evaporation and Absorption– When lotion is rubbed into the skin water
evaporates and the oil droplets coalesce• Coalescence occurs when the interfacial energy
between substrates and adatoms is small– The clusters can detach themselves from any given
location on the surface and diffuse as entities over the surface
– The clusters behave more like liquid than solid crystallites
Product Attributes
• Evaporation and Absorption– After the application of the lotion the
composition changes as the water and other other volatiles solvents evaporate
– A film stays on the skin as a protector and the nutrients are absorbed
– Absorption capacity increases with decreasing viscosity
Product Attributes
• Viscosity– Emulsion size and concentration determines the
viscous properties– At the same shear stress and droplet
concentrations the viscosity of concentrated emulsions containing smaller droplets was significantly greater
– This suggests that electrostatic repulsion plays an important role in determining the rheology of concentrated emulsions
Product Attributes
• Viscosity– The droplets become closely packed causing
the emulsions to be come rigid at lower concentrations for smaller droplets because of their effective volume fraction is greater
– This explains why low emulsifier concentrations are good for structured lotions
– Lotions are not suppose to be very thick and viscous
Product Attributes
• Fragrance– Fragrances are applied by collodial systems like emulsions– The lipid part of the stratum corneum is organized in
lamellar structures – The lamellar liquid crystals in lotions contain the
fragrance molecules – The similarity of the configuration of the crystals in lotion
compared to the stratum corneum is why it easy for the fragrance to be absorbed into the skin
– The location of the interlayer spacings and the geometrical characteristics play a big role on where the location of the fragrance is
Product Attributes
• Improvements made to the skin– Liposomes have positive effects on the appearance of
the skin – Improve cutaneous hydration, skin structure, depths of wrinkles
– Liposomes are spherical vesicles that have an aqueous cavity at their center
– They are used to carry water-soluble molecules and hydrophobic molecules
– Liposomes have been evaluated as delivery systems for drugs, vitamins and cosmetic materials
Product Attributes
• Delivery Systems– Particulate systems are very small particles that
range from micrometers to millimeter – These particles deliver essential active
ingredients such as amino acids, plant extracts, minerals, vitamins, antioxidants, and UV protectants
– They also prolong the time during which the ingredient remains on the skin
VI. Manufacturing Process
• The objective is to disperse one liquid within another in an extremely fine form to make certain that separation due to settling either does not occur or takes place very slowly.
• Does not normally involve any extraction or chemical reaction.
A Few Parameters that may influence liquid-liquid emulsion formation
• Shear rate• Sufficient stabilizers need to be present to
maintain the smallest droplet size produced for long periods of time.
• Blend time and standard deviation of circulation time.
• These along with many other parameters make it difficult to specify a mixing process based on desired droplet size. Most predictions are based on existing data.
Federal Rules and Regulations
• CGMP’s – Primary objective is to ensure that manufacturers provide consumers with safe and effective products.
• Parts 210 and 211 apply to manufacturing of drugs and finished pharmaceuticals.
• Part 210 contains a basic overview and some definitions that are used in Part 211.
Part 211
• Gives a description of responsibilities of the quality control unit.
• States that proper training procedures must be in place.
• Buildings and Facility requirements• Cleaning requirements- Rooms and Equipment• Proper labeling and storage of materials• Batch Records