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Reviewer for Ointments, gel and creams Phardose
  Ointments, Creams, and Gels Topicals    –  preparations applied to the skin either for their physical effects or for the specific effect of a medicinal agent.    Protectants    Lubricants    Emollients    Drying agents     Astringents Transdermals    –  designed to support the passage of drug substances from the surface of the skin,through its various layers, and even into the systemic circulation. Functions of Dermatologicals 1.   Protect injured areas from the environment 2.   Provide skin hydration (emollient) 3.    Vehicle for medical transport Drug Penetration is dependent upon:     Amount of pressure and vigor of rubbing    Surface area covered    Condition of the skin    Base used    Occlusive dressings used  Application Areas for Dermatologicals LOTIONS   Intertriginous areas CREAMS   moist, weeping lesions OINTMENTS   Dry, scaly lesions Ointments  –    semisolid preparations intended for external application to the skin or mucous membranes.    Easily spread    Modifying formulation controls their plastic viscosity 2 types: 1.   Medicated  –  with active ingredient 2.   Non-medicated  –  ointment bases  OINTMENT BASES 1. Oleaginous bases  –    aka hydrocarbon bases.    Have emollient effect after application    Water insoluble    Non-washable    Cannot absorb water    Oily, occlusive, lack cosmetic appeal Examples: a. Petrolatum, USP    –  good base for insoluble ingredients b. White petrolatum, USP    –  yellow wax is decolorized (bleached and purified yellow wax) c. Yellow Ointment, USP    –  aka simple ointment; -  yellow wax - purified wax obtained from honeycomb of the bee Apis mellifera d. Lanolin derivatives e. Synthetic esters  –    constituents of oleaginous - glyceryl monostearate, butyl stearate, isopropyl lanolate , stearyl alcohol  2. Absorption Bases    Water insoluble    Non-washable    Can absorb water     Anhydrous    Oily, occlusive, lacks cosmetic appeal Examples: a. Hydrophilic petrolatum  –    w/o emulsifier  b. Aquaphor    –  has the capacity to absorb up to 3x its weight in water c. Aquabase  –   d. Wool fat (anhydrous lanolin)  –    from wool of sheep (Ovis aries) -   Higher percentage of cholesterol -    Ability to absorb twice its weight  3. Water-Removable bases  –   o/w emulsions; aka emulsion bases. 2 types: a. Water in oil    water insoluble    non-washable    can absorb water    contains water Examples:    cold cream (petrolatum rose water ointment)    Lanolin (hydrous wool fat)    Hydrophilic ointment     Vanishing creams b. Oil in water      water insoluble    water washable    can absorb water    contains water Examples:    Hydrophilic ointment     Velvachol    Unibase     Acid mantle    Dermabase     Vanicream Humectants  –  hydrating agent    Glycerin    Propylene glycol    Sorbitol 70% 4. Water Soluble bases    Water soluble    Water washable    Can absorb water     Anhydrous or hydrous     All water soluble, no oil phase Examples:  polyethylene glycol ointment  Veegum  Methods of Preparation: 1.   Fusion  –  heating all ingredients. Let cool and congeal. 2.   Mechanical incorporation - performed by trituration in a mortar or on a slab with spatula is a process knwon as levigation. COMPEDIAL REQUIREMENTS FOR OINTMENTS: 1.   Microbial content  –  test for absence of Staphyloccocus aureus and Pseudomonas aeruginosa.       Addition of preservatives such as methyparaben, propylparaben,phenols, benzoic acid, sorbic acid, and quarternary ammonium salts 2.   Minimum fill  –  to ensure proper contents compared with labeled amount. - 30% max (overage) - 10% minimum 3.   Packaging, storing, and labeling Packaging  –  jar: glass, plastics ( DO NOT POUR WHILE HOT) -  dispensing jars: plastic -  tubes: plasitc, tin, aluminum Labeling  –   protect w/ tape - Dual labels Storage    –  store in a cool place 4.    Additional standards    Sterility and metal particles content for ophthalmic ointment SELECTION OF APPROPRIATE BASE:    Topical or percutaneous drug absorption    Release rate    Occlusion    Stability of the drug    Effect of drug on ointment base    Easy removable    Characteristics of surface for application Creams  –    containing one or more mediciinal agents dissolved or dispersed in either w/o or water- washable base. Examples: vanishing creams; easily spread, easy removed Gels  –   dispersions of small or large molecules in n aqueousliquid vehicle rendered  jellylike by the addition of a gelling agent. AKA jellies.
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