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US 6,271,219 B1Granted
Topical formulations comprising skin penetration agents and the use thereof
OwnerRajaram Vaidyanathan, Phuong M. Vo +4inventors
InventorsRajaram Vaidyanathan, Phuong M. Vo, George N. Manning, Donald J. Gerhart, Atef A. Helmy, Geoffrey Allan
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Abstract
Disclosed are topical pharmaceutical compositions comprising a pharmaceutically active agent such as a corticosteroid, a diol, cetyl alcohol, glyceryl monostearate, laurocapram, stearyl alcohol, sodium lauryl sulfate and water. Also disclosed is a method for the manufacture of the compositions and methods for treating inflammatory skin conditions with the compositions.
Claims18
A pharmaceutical composition for topical administration, comprising:
- (a) a safe and pharmaceutically effective amount of a pharmaceutically active agent;
- (b) about 15-97% by weight of a diol selected from the group consisting of 1,2-propanediol, 1,2-butanediol, 1,3-butanediol, 2,3-butanediol, and mixtures thereof;
- (c) about 0.5-25% by weight of cetyl alcohol;
- (d) about 0.1-25% by weight of glyceryl monostearate;
- (e) about 0.9-5.0% by weight of laurocapram;
- (f) about 0.5-25% by weight of stearyl alcohol;
- (g) about 0.01-1.0% by weight of sodium lauryl sulfate;
- and
- (h) water.
6 more elements
A process for preparing a topical pharmaceutical composition, comprising:
- (a) admixing water, a diol and sodium lauryl sulfate at about 70-80° C. at least until the diol and sodium lauryl sulfate dissolves to give an Aqueous Phase Mixture Part A, wherein said diol is selected from the group consisting of 1,2-propanediol, 1,2-butanediol, 1,3-butanediol, 2,3-butanediol, and mixtures thereof;
- (b) admixing laurocapram and a pharmaceutically active agent at about 70-80° C. at least until the corticosteroid dissolves to give a Agent/Laurocapram Premix Part B;
- (c) admixing glyceryl monostearate, cetyl alcohol and stearyl alcohol at about 70-80° C. until at least the admixture melts;
- (d) admixing with said melted admixture said Agent/Laurocapram Premix Part B at about 70-80° C. and mixing at least until thoroughly blended to give an Oil (non-aqueous) Phase Mixture Part C;
- (e) emulsifying a mixture of Aqueous Phase Mixture Part A and the Oil (non-aqueous) Phase Mixture Part C at about 70-80° C.;
- and
- (f) cooling to room temperature.
4 more elements
Dependencies are inferred from the claim text.