Compatibility of Active Pharmaceutical Ingredients in Cleoderm™: A Comprehensive Study for Enhanced Topical Dermatological Treatments.

Abstract

Background: This study investigates the compatibility and stability of active pharmaceutical ingredients (APIs) in Cleoderm™, a dermatological cream designed for the treatment of acne vulgaris, hyperpigmentation, dermatitis and other skin conditions. Cleoderm™ is formulated with hyaluronic acid and Cleome gynandra L., recognized for their sebum-regulating and anti-inflammatory properties. Complementary ingredients, such as palmitoyl tripeptide-8, bisabolol, and functional oils, contribute to the cream's antioxidant and anti-inflammatory effects.

Method: High-performance liquid chromatography (HPLC) was employed to assess the compatibility of APIs in Cleoderm™. Forced degradation studies were conducted to evaluate API stability under diverse stress conditions.

Result: The study established beyond-use dates (BUDs) for the tested formulations stored at room temperature. Adapalene (0.1%), dapsone (5% to 10%), and hydroquinone (10%) exhibited BUDs of 180 days. Throughout this period, no discernible physical alterations were observed in the formulations, and their chemical stability remained within acceptable parameters. Comprehensive microbiological assessments affirmed the efficacy of the preservative system.

Conclusion: These findings underscore Cleoderm™'s potential as a dependable vehicle for compounded dermatological preparations. The study underscores the significance of continuous stability assessments and quality control protocols in formulating personalized and efficacious treatments for acne vulgaris and other inflammatory dermatoses. Progress in this field holds promise for enhancing therapeutic options and outcomes for individuals affected by these conditions.