FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS OF GRANISETRON

Faiz Ahmed Khan*, R. R. Pagore, R. S. Radke, Mohd. Avez, Shahid R. Shekh

The present study aimed to formulate and evaluate fast dissolving oral films (FDOFs) of Granisetron to improve patient compliance and provide rapid drug release for the effective management of nausea and vomiting. Granisetron oral films were prepared by the solvent casting method using hydroxypropyl methylcellulose and methyl cellulose as film-forming polymers. Six formulations (F1–F6) were developed with varying polymer concentrations and evaluated for physicochemical properties including weight variation, thickness, folding endurance, surface pH, drug content uniformity, disintegration time, and in-vitro drug release. Drug–excipient compatibility was assessed using Fourier Transform Infrared Spectroscopy (FTIR). Stability studies of the optimized formulation were conducted for three months. FTIR studies confirmed the compatibility of Granisetron with the selected excipients, showing no significant drug–excipient interaction. The prepared films exhibited satisfactory physicochemical characteristics with weight variation ranging from 214.69 ± 0.45 to 216.50 ± 0.10 mg, thickness from 0.24 ± 0.1 to 0.26 ± 0.3 mm, folding endurance from 200 ± 4 to 248 ± 3 folds, surface pH from 6.45 ± 0.05 to 6.75 ± 0.03, and drug content from 95.10% to 98.70%. All formulations disintegrated rapidly within 49–52 s. In-vitro dissolution studies demonstrated rapid drug release, with formulation F4 showing the highest cumulative release of 99.75 ± 3.10% within 10 min. Stability studies revealed no significant changes in drug content, disintegration time, folding endurance, or drug release after three months of storage. The developed Granisetron fast dissolving oral films exhibited excellent physicochemical properties, rapid disintegration, and efficient drug release. Among all formulations, F4 was identified as the optimized formulation owing to its superior mechanical properties, highest drug content, fastest disintegration, and maximum drug release. The study demonstrates the potential of fast dissolving oral films as an effective and patient-friendly delivery system for Granisetron.