Formulation and Evaluation of Buccal Thin Films of Ondansetron Using Biodegradable Natural Polymers (Chitosan-Gelatin) for Rapid Onset of Action

Abstract

The present investigation was designed to develop and assess buccal thin films of Ondansetron HCl using biodegradable natural polymers for rapid onset of antiemetic action. Ondansetron HCl was chosen as the model drug because of its established clinical relevance in nausea and vomiting, where administration of conventional oral dosage forms can be problematic. Buccal thin films were produced by the solvent casting technique with chitosan as a mucoadhesive polymer and gelatin as a biodegradable film-forming polymer, with glycerol as plasticizer. Six formulations, OBF1 to OBF6, were developed by varying chitosan and gelatin concentrations. The films were subsequently assessed for appearance, thickness, weight variation, folding endurance, surface pH, moisture content, swelling index, drug content, content uniformity, mucoadhesive residence time, hydration time and in vitro drug release. All formulations showed acceptable physical and pharmaceutical characteristics. Among them, OBF4 provided the most suitable balance of flexibility, surface pH, swelling, mucoadhesion, drug content and rapid release, with 95.36% drug release within 15 min. Stability testing indicated acceptable stability of the optimized formulation.