Development and Evaluation of Polymeric Film Forming Solution of Ciclopirox Olamine for Topical Fungal Therapy

Abstract

Aim: Formulation and assessment of polymeric film forming solution (PFFS) loaded with Ciclopirox olamine (CPO) for managing topical fungal infections. Methods: PFFS was prepared using a common solvent method with a range of polymers, such as Eudragit RL 100, Eudragit RS 100, PVP K30, PVP K90, HPC, HPMC K15, HPMC K4M, and PEG 400 in ethanol. The formulated PFFS was evaluated for Physicochemical properties, In vitro drug release, ex vivo permeation studies, stability studies, and antifungal assay. Results: The formulations have exhibited drying time of less than one minute. Most of them demonstrated uniform film formation, with an acceptable viscosity and pH within permissible limits, and with minimal outward stickiness. PFFS TR2 with CPO, Eudragit RL 100, and PEG 400 showed an In vitro drug release rate of 83.17% over 12 hours with controlled release kinetics. Ex vivo studies revealed a cumulative permeation of 1341.04 µg/cm² over 24 hours with a flux of 68.31 µg/cm²/hr, characterized by anomalous diffusion (non-Fickian transport), Moreover, the TR2 formulation achieved significant antifungal efficacy, with a zone of inhibition measuring 20±0.9 mm. Complementary characterization via FT-IR (Fourier Transform Infrared Spectroscopy) and DSC (Differential Scanning Calorimetry) confirmed the absence of drug-excipient interactions. Conclusion: The above study concludes that PFFS using Eudragit RL 100, Menthol: camphor, and PEG 400 showed enhanced antifungal activity and controlled release, suggesting it as a promising method for topical fungal treatment.