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Introduction To Topical Medications
Topical preparations:
1. Preparations applied to the skin either for their physical effects or for the specific effect of a medicinal agent.
2. They maybe applied to skin, placed on surface of eye, or used nasally, vaginally or rectally.
3. They can be medicated or non medicated.
4. Used as Protectants, lubricants, emollients, drying agents, astringents.
ointment
• Semi-solid dosage forms
• Applied to skin or mucous membrane
• Medicated or non medicated
• Un-medicated are used for physical effects such as emollient, protectant, lubricants.
Oleaginous bases
• Water insoluble• Not water washable• Can’t absorb water• Oily, occlusive, lack cosmetic
appeal
Examples:1. Hydrocarbons (mineral oils,
petrolatums, paraffins, waxes)2. Animal fats/vegetable oils (castor
oil, cottonseed oil, olive oil)3. Synthetic esters (glyceryl
monostearate, butyl stearate, isopropyl lanolate, stearyl alcohol)
4. WHITE PETROLATUM5. WHITE OINTMENT
absorption bases
•Water insoluble•Not water washable•Can absorb water•Anhydrous•Oily, occlusive, lacks cosmetic appeal
Examples:1. Hydrophilic petrolatum2. Bees wax 3. lanolin
water-removable bases
• Water Washable• Can Absorb Water• External Phase Contains
Water
Examples:•Hydrophilic Ointment
water-soluble bases
• Water soluble• Water washable• Can absorb water• Anhydrous or hydrous• All water soluble, no oil phase
Example:•Polyethylene Glycol Ointment•Biozyme Ointment, Desenex Ointment
selection of ointment bases
Depends upon
• Release rate• Topical or percutaneous drug
absorption• Occlusion• Stability of drug• Effect of drug on ointment
base• Easily removable• Characteristics of surface for
application
preparation of ointment
•Ointment Slab/Pill Tile•Mortar/Pestle•Ointment Mill•Fusion
Heat highest melting point material first
Water phase a few degrees higher
W/O: add water slowly O/W: add oil slowly
• Incorporation Mortar and pestle or spatula is
used Materials are rubbed on a slab Material of spatula is stainless steel
or rubber Ointment is prepared by thoroughly
rubbing solid material in base
packaging
• Jars: Glass, Plastic Do not pour in while hot!
• Disp. Jars: Plastic
• Tubes: Plastic, tin, aluminum
• Syringes: Individually dosed, good protection of the product
creams
•Opaque, soft solids, or thick liquids intended for external application
•Can be of two types
o/w
w/o
manufacturing area
1.Wax melting device
2.Water heating device
3.Manufacturing vessel
4.Storage vessels
5.Automated panel
manufacturing of creams
Wax melting vessel
Water heating vessel
Mfg vessel
Silverson mixerPaddle mixerWater and steam jacketed
Wat
er
Wax
Wax, water, antioxidants, emulsifying agents, preservatives
60-80 0C
SS316
Muslin cloth
SS316
Temp gauge
gels
•Semisolid systems consisting of dispersions of small or large molecules in an aqueous liquid vehicle rendered jelly-like through the addition of a gelling agent.
Types of gels
•Single Phase
• Gels in which the macromolecules are uniformly distributed throughout a liquid with no apparent boundaries between the dispersed macromolecules and the liquid
• Usually involve organics
•Two Phase
• When the gel mass consists of floccules of small distinct particles
• Usually involve inorganics
gels
Composition of gels
• Gelling agent• Water• Cosolvents• Preservatives• Stabilizers
Kinds of Gels
1. Hydrogels• Silica, bentonite, pectin, sodium
alginate, methylcellulose, alumina
2. Organic Gels• Contain an organic liquid (e.g.,
Plastibase)
3. Carbomer Gels• Aqueous dispersion neutralized with
sodium hydroxide or triethanolamine
4. Methylcellulose Gels5. Starch Glycerite6. Aluminum Hydroxide Gel
Phenomena Associated with Gels
•Syneresis- When the interaction between particles of the dispersed phase becomes so great that on standing, the dispersing medium is squeezed out in droplets and the gel shrinks
•Swelling- The taking up of liquid by a gel with an increase in volume
•Imbibition- The taking up of a certain amount of liquid without a measurable increase in volume
•Thixotropy- A reversible gel-sol formation with no change in volume or
temperature•Jelene/Plastibase
- A combination of mineral oils and heavy hydrocarbon waxes with a MW of about 1300
•Carbomer 934- A polymer of acrylic acid cross-linked with a polyfunctional agent; recognized as an official emulsifying and suspending agent
phenomenon associated with gels
Applications of gels•Oral•Topical•Intranasal•Vaginal•Rectal
Gelling agents
1. Carbomer2. Cmc3. Tragacanth4. Gelatin5. Aerosil
applications and gelling agents
gelling agents
Carbomers:1. Acrylic based2. Sustain release in stomach3. Thickening agent4. Used in conc of 0.5-1%
Carboxy methyl cellulose:
5. Used in conc of 4-6%6. Viscosity enhancer7. Insoluble in water but salts
are soluble in water such as sodium CMC
Tragacanth• Soaked overnight• Used with glycerine and
propylene glycol as wetting agent
Gelatin• Obtained from bone
collagen• Bio-compatible• cosmotological• Contains human serum
albumin
Ehtyl cellulose• 5% conc
Aerosil• Inorganic• No microbial growth
•Physical Stability- Shrinkage- Separation of liquid from the gel- Discoloration
•Microbial Stability•BUD: Unless otherwise documented, 14 days when stored in a refrigerator (USP)
Stability
Packaging/Storage/Labeling
•Tight containers•Room or refrigerated temperatures, as appropriate•Prior to use, store in tight containers.
pastes
• Thick, stiff ointments that do not ordinarily flow at body temperature.
• Serve as protective coatings over the areas to which they are applied.
• Usually >20% solids
• Medicated (zinc oxide)
• Un-medicated (toothpaste)
• Bulking agent calcium carbonate, starch.
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