FORMULATION, DEVELOPMENT AND OPTIMIZATION OF FAST DISSOLVING ORAL FILMS OF ONDANSETRON
The present study aims to formulate fast-dissolving oral films of ondansetron 8 mg. Ondansetron, a Serotonin 5-HT3 receptor antagonist, is a powerful antiemetic drug with an oral bioavailability of 60% due to hepatic first-pass metabolism and a short half-life of 5 hours. It is primarily used to prevent nausea and vomiting associated with emetogenic cancer chemotherapy, postoperative conditions, and radiation. Additionally, it is employed in the treatment of postoperative nausea and vomiting. This study also focuses on the formulation and optimization of ondansetron fast-dissolving oral films using the Box-Behnken experimental design. The films are prepared by the solvent casting method and will be subjected to various evaluations, including physical appearance and surface texture, drug content, weight variation, film thickness, folding endurance, surface pH, moisture loss studies, dispersion test, disintegration, and in vitro dissolution studies. Findings from the investigation revealed that combination of two or more polymers at appropriate levels may result in fast dissolving film with improved characteristics as compared to monopolymeric film. Three factors, three levels BoxBehnken design was used to derive optimized fast dissolving film formulation. Analysis of variance (ANOVA) was performed for three dependent variables thickness, disintegration time and drug release. Based on the evaluation parameters, the formulation F5 showed optimum performance against other formulations