Design, Formulation and Evaluation of Buccoadhasive Fast Dissolving Oral Films Containing 5-Ht3 Receptor Antagonist Drug

Oral route is most preferred route by medical practitioners and manufacturer due to highest acceptability of patients. About 60% of all dosage forms available are the oral solid dosage form. The lower bioavailability, long onset time and dysphagia patients turned the manufacturer to the Parenterals and liquid orals. Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. It improves the efficacy of APIs by dissolving within minute in oral cavity after the contact with saliva without chewing and no need of water for administration. It gives quick absorption and instant bioavailability of drugs due to high blood flow and permeability of oral mucosa is 4-1000 times greater than that of skinFast dissolving Oral film of Granisetron Hydrochloride was formulated by using solvent casting method with different concentrations of HPMC-E3, E6 and E15. Film forming property of various grades of HPMC was investigated based on preliminary characteristics of various batches of FDOFs. Formulations with HPMC E3 were not evaluated for other physical parameters due to their poor film forming ability, tack property and ease of handling or peeling. The bitter taste of the drug was masked by Aspartame and Vanilla flavour. Formulations with HPMC E6 and E15 were evaluated for their physical characteristics, thickness, folding endurance, tensile strength, disintegration time, drug content uniformity and drug release characteristics. Dissolution studies were performed for FDOFs excluding batches that showed poor film forming property. Among the prepared formulations F9 showed minimum disintegration time 12 sec. Formulation F9 released 97.8% of drug within 8 min when compared to the other formulations. Based on the physicochemical properties like tensile strength, folding endurance, thickness, disintegration results and dissolution studies, it was concluded that F9 finalized as optimized formulation. DSC and FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug.