A compound ketoconazole foam composition and its preparation method and application

Abstract

This invention relates to the field of topical dermatological drug formulations, specifically to a compound ketoconazole foam composition, its preparation method, and its application. The foam composition comprises the following components: 100 parts by weight of a drug solution and 8-12 parts by weight of a liquid propellant; the drug solution comprises the following raw materials: 1.0-3.0 wt% ketoconazole, 0.10-0.40 wt% clobetasol propionate core-shell microcapsules, 3-10 wt% oil phase solvent, 1-5 wt% foam support agent, 2-5 wt% surfactant, 0.05-0.3 wt% foam stabilizer, 5-15 wt% humectant, 0.5-1.0 wt% cholesterol isostearate, a pH adjuster to adjust the pH of the drug solution to 6-8, and water to a final volume of 100 wt%; the clobetasol propionate core-shell microcapsules have a core-shell structure with a cellulose compound as the shell material and clobetasol propionate as the core material. This invention avoids the problems of poor stability, foam quality, and patient compliance caused by the difficulty in coordinating the large differences in the physicochemical properties of clobetasol propionate and ketoconazole when they are combined in a compound foaming agent.

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