Preparation and Pharmaceutical Evaluation of Miconazole Nitrate Mucoadhesive Films for Vaginal Candidiasis

Abstract

Background: Mucoadhesive dosage forms including tablets, gels, ointments, patches, and films have received great attention during recent years. They facilitate the topical release and hence better absorbance of the drug. We tried to design miconazole nitrate mucoadhesive films to affect vaginal candidiasis. Methods: The prepared polymeric films contained 10 mg miconazole nitrate, mucoadhesive polymers (hydroxypropyl methylcellulose 6cps and K15M, chitosan, and Eudragit RL100), and propylene glycol (PG) as solvent and plasticizer. These films were made by solvent casting method. The films were assessed in terms of various physical and pharmaceutical properties such as thickness, swelling capacity, surface pH, disintegration time, miconazole nitrate loading, in vitro drug release, mucoadhesion, and antifungal effect against Candida albicans compared to miconazole vaginal cream. Findings: The mean weight and thickness of suitable films were 0.022 g and 148 micron, respectively. The highest miconazole nitrate loading was 9.5 mg. Swelling index, time of disintegration, and adhesiveness of films were acceptable. Conclusion: The films containing hydroxypropyl methylcellulose K15M had a uniform appearance and adequate strength and adhesion with optimum release pattern in five hours. Keywords: Vaginal candidiasis, Miconazole nitrate, Mucoadhesive film