Critical Attribute Considerations in Designing Systems for Sustained Topical Delivery of Hydrophobic Drugs for the Treatment of Acne Vulgaris

Background/Objectives: A matrix system for topical application was developed for a hydrophobic drug model, benzoyl peroxide (BPO), by turning it into its amorphous state to increase its bioavailability. BPO is commonly used to treat acne vulgaris; however, the commercially available products possess several drawbacks including poor absorption due to large crystal size and thus reduced efficacy and skin irritation. Methods: Several polymeric films containing amorphous BPO were successfully prepared for the first time from polymer + plasticizer colloidal dispersions and characterized. Results: The loaded BPO maintained its amorphous state even after 24 months of storage at 5 °C, and drug release could be modulated by adjusting the film compositions. The prepared films were obtained by solvent evaporation, and residual acetone remained below the level of quantification of the analytical method. In addition, the films were thin, flexible, transparent, bioadhesive, and able to remain on the skin for a clinically relevant period. Microscopic imaging confirmed a homogeneous and continuous morphology. Conclusions: The developed formulations may represent promising alternatives for the treatment of acne vulgaris.