Percentage of Excipients Used in Cream Formulation


Pharmaceutical cream is a semisolid dosage form either the oil-in-water or water-in-oil type. It may also contain one or more drug substances dissolved or dispersed in a suitable cream base. Here we mention a list of common excipients used in the cream preparation with recommended percentage.


A List of Excipients Used in Cream Preparation

• Acacia – 10 to 20% (as an emulsifying agent)

• Alcohol – 60 to 90% (as a solvent in topical formulation)

• Alpha Tocopherol – 0.001 to 0.05% v/v (as an antioxidant)

• Ascorbic Acid – 0.01 to 0.1% w/v (as an antioxidant)

• Bentonite – 1% (as an emulsion stabilizer)

• Benzoic Acid – 0.1 to 0.2% (as an antimicrobial preservative)

• Butylated Hydroxyanisole – up to 0.02% w/w (as an antioxidant)

• Butylated hydroxytoluene - up to 0.1% w/w (as an antioxidant)

• Butylparaben – 0.02% to 0.4% (as an antimicrobial preservative)

• Cetostearyl Alcohol – amount may vary (as an emulsifying agent)

• Cetyl alcohol – 2 to 5% (as an emulsifying agent or emollient)

• Chlorocresol – 0.075 to 0.2% (as an antimicrobial preservative)

• Citric Acid Monohydrate – amount may vary (as an acidifying agent)

• Glycerin – up to 30% (as an emollient)

• Isopropyl alcohol – amount may vary (as a solvent)

• Isopropyl myristate – 1 to 10% (as an emollient or oleaginous vehicle)

• Isopropyl palmitate – 0.05 to 5.5% (as an emollient or oleaginous vehicle)

• Lactic acid – 0.015 to 6.6% (as an acidifying agent)

• Lanolin – amount may vary (as a hydrophobic vehicle)

• Linoleic Acid - amount may vary (as an emulsifying agent)

• Methyllparaben – 0.02 to 0.3% (as an antimicrobial preservative)

• Mineral oil – 1 to 32% (as an emollient)

• Myristic acid – amount may vary (as an emulsifying agent or skin penetrant)

• Myristyl alcohol - amount may vary (as an emulsifying agent or skin penetrant)

• Oleic acid - amount may vary (as an emulsifying agent or skin penetrant)

• Palmitic acid - amount may vary (as an emulsifying agent or skin penetrant)

• Paraffin - amount may vary (as an ointment base)

• Poloxamer – 0.01 to 5% (as a wetting agent)

• Polyethylene glycol - amount may vary (as an ointment base)

• Propylene glycol – around 15% (as a humectant)

• Propylene glycol – 15 to 30% (as a preservative)

• Propylparaben – 0.01 to 0.6% (as an antimicrobial preservative)

• Sorbic acid – 0.05 to 0.2 5 (as an antimicrobial preservative)

• Stearyl alcohol – amount may vary (as a stiffening agent)

• Thimerosal – 0.01% (as an antimicrobial preservative)

• Triolein - amount may vary (as an emollient or penetration enhancer)

• Wax, Anionic Emulsifying – up to 10% (as an emulsifying agent)

• Wax, Cetyl Esters – 1 to 15% (as an emulsifying or stiffening agent)

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