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Semisolid Dosage Form Bulk Ointments Creams Pastes Gels Unit Suppositories Pessaries
Semisolid Dosage Forms Pharmaceutical semisolid preparations : Topical products intended for application on the skin or accessible mucous membranes to provide localized and sometimes systemic effects at the site of application. The physical properties of the dosage form depend on various factors, including Size of the dispersed particles The interfacial tension between the phases Partition coefficient of the active ingredient between the phases Product rheology.
The design of a semisolid preparation is based on its ability to adhere to the surface of application for a reasonable duration before they are washed or worn off. - brought about by a plastic rheologic behavior Medicated- Majority Non-medicated - protectants and lubricants.
Ointments are composed mostly of fluid hydrocarbons meshed in a matrix of higher melting solid hydrocarbons. Creams are semisolid emulsion systems with an opaque appearance. Their consistency and rheologic properties are based on whether the emulsion is o/w or w/o and on the nature of the solid in the internal phase. Pastes are basically ointments into which a high percentage of insoluble solids has been added. Powders such as zinc oxide, titanium dioxide, starch and kaolin are incorporated in high concentrations into a preferably lipophilic greasy vehicle to form a paste-like mass.
OINTMENTS Ointments are composed mostly of fluid hydrocarbons meshed in a matrix of higher melting solid hydrocarbons. General Uses Of Ointments 1.Acts as protective or protectant – serve as physical barrier to environment 2.Acts as emollient – softens skin and makes it pliable 3. Carrier of medicament - vehicle
The USP and NF Classify Ointment Bases into Four General Groups 1. Hydrocarbon bases or Oleaginous bases 2.Absorption bases 3.Water removable bases or Emulsion Ointment bases 4.Water soluble bases
Hydrocarbon bases Oleaginous bases Emollient effect Occlusive dressing Difficult to wash-off/remove Is greasy and can stain clothing.
Hydrocarbon bases 1.Petrolatum, USP Yellow petrolatum/petrolatum jelly/yellow soft paraffin Vaseline (Chesebrough-Ponds/Unilever) (vahser-elaion) 2.White petrolatum, USP Decolored petrolatum/white soft paraffin, White petroleum jelly/white vaseline 3.Yellow ointment, USP Yellow wax (5%, w/w), petrolatum (95%) yellow hard paraffin 4.White ointment, USP White wax/white petrolatum white hard paraffin 5.Mineral oil / liquid paraffin These are useful as levigating agents to wet and incorporate solid substances
Absorption bases Those that permit the incorporation of aqueous solution resulting in the formation of w/o emulsions -- hydrophilic petrolatum, USP Cholesterol 30 g, Stearyl alcohol 30 g White wax 80 g, White petrolatum 860 g --Aquaphor: A gentle healing ointment to help heal dry, cracked skin (Petrolatum. Other Ingredients: Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol) Those that are w/o emulsion Hydrous lanolin: w/o emulsion containing 25% of water lanolin USP: Anhydrous, contains < 0.25% of water, absorbs twice its weight in water, also called wool wax, wool fat, or wool grease, a greasy yellow substance from wool-bearing animals, acts as a skin ointment, water- proofing wax, and raw material (such as in shoe polish).
Properties of absorption bases Absorption bases (anhydrous) Emollient Occlusive Absorbs water Greasy W/O emulsion Emollient Occlusive Contains water, absorbs additional water Greasy
Water-removable bases Water-washable bases, O/W emulsion Hydrophilic ointment, USP Methylparaben 0.25 g Propylparaben 0.15 SDS 10 Propylene alcohol 120 Stearyl alcohol 250 White petrolatum 250 Water 370 Vanishing cream: o/w emulsion contains la large % of water and humectant. An excess of stearic acid in the formula helps to form a thin film when the water evaporates.
Properties of water-removable bases Water-washable, easier to remove Non/less greasy Can be diluted with water Non/less occlusive Better cosmetic appearance Better compliance
Properties of water-soluble bases Water soluble and washable Non-greasy Non/less occlusive Lipid free Synthetic base
Cream Semisolid preparations containing one or more medicinal agents dissolved in either an o/w or w/o emulsion or in another type of water-washable base. Vanishing cream: o/w with high % of water and stearic acid. Cold cream: (an emulsion for softening and cleansing the skin): w/o, white wax, spermaceti, almond oil, sodium borate.
PASTES Pastes maybe defined as ointments incorporating a high percentage of insoluble particulate solids, sometimes as much as or more than 50%.
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