Design and Evaluation of Itraconazole-Loaded Mucoadhesive Buccal Films for Enhanced Antifungal Bioavailability

Abstract

The present study aimed to design and evaluate itraconazole-loaded mucoadhesive buccal films using natural polymers to enhance local antifungal therapy and oral bioavailability. Itraconazole, a poorly water-soluble antifungal agent, exhibits limited oral absorption and variable systemic exposure, making buccal delivery a promising alternative for treating oral candidiasis. Buccal films were prepared by the solvent casting method employing chitosan and sodium alginate either alone or in combination. All formulations demonstrated acceptable physic mechanical properties, including uniform thickness, smooth surface, adequate folding endurance, near-neutral surface pH, and uniform drug content. FTIR studies confirmed drug–excipient compatibility. In vitro release studies revealed rapid drug release from chitosan films, while chitosan–alginate blends provided sustained release suitable for prolonged buccal residence. Release kinetics followed Zero-order and Korsmeyer–Peppas models, indicating diffusion-controlled drug release. Among all batches, formulation F6 showed optimal mucoadhesion, extended residence time, and sustained itraconazole release for up to 8 hours, with good stability under accelerated conditions. The developed buccal films offer a promising patient-friendly approach for effective localized antifungal therapy.