Compatibility of Active Pharmaceutical Ingredients Combinations Compounded in Cleoderm™, a Cream Base for Personalized Dermatological Treatments
Author(s): Marianni Bruna, Silva Carolina Costa Vicente, Polonini Hudson
Issue: Mar/Apr 2025 - Volume 29, Number 2
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Page(s): 150-162
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Abstract: The increasing prevalence of skin conditions like acne, rosacea, and hyperpigmentation highlights the need for personalized dermatological treatments, with compounded formulations providing tailored solutions by combining multiple active pharmaceutical ingredients (APIs). This study evaluates the compatibility and stability of various formulations compounded in Cleoderm™, a cream base designed for acne-prone, affected, or sensitive skin. The tested formulations included: adapalene 0.1% or 0.3% and benzoyl peroxide 1.0% or 5.0%; hydroquinone 4.0%, hydrocortisone 1.0%, and tretinoin 0.0125%; azelaic acid 15.0% or 20.0% and niacinamide 4.0%; niacinamide 4.0% and tretinoin 0.025%; and clindamycin hydrochloride 3.0%. Each formulation underwent high-performance liquid chromatography (HPLC) and microbiological assessments over a 180-day period to determine stability and beyond-use dates (BUDs). Both formulations containing adapalene and benzoyl peroxide demonstrated excellent stability, with an assigned BUD of 180 days. Formulations of azelaic acid combined with niacinamide and niacinamide with tretinoin also showed sustained stability with BUDs of 180 days. In contrast, the formulation containing hydroquinone, hydrocortisone, and tretinoin had a BUD of 14 days. Clindamycin hydrochloride displayed a similar pattern, with stability maintained for 14 days. Microbiological evaluations confirmed the antimicrobial efficacy of all formulations, meeting United States Pharmacopeia (USP) requirements for antimicrobial effectiveness throughout their respective BUDs. The findings underscore the importance of evaluating the stability and compatibility of compounded formulations to ensure their safety and efficacy. This study supports the use of Cleoderm™ as a versatile and reliable base for personalized dermatological treatments, providing evidence-based BUDs to guide clinical practice.
Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS