Background: Ondansetron is a widely used serotonin 5-HT3 receptor antagonist for managing chemotherapy-induced, radiation-induced, and postoperative nausea and vomiting. Conventional oral solid dosage forms present challenges for patients experiencing nausea and vomiting, who often have difficulty swallowing. Oral fast dissolving films (ODFs) offer a promising alternative by providing rapid disintegration in the oral cavity without requiring water, potentially improving patient compliance and therapeutic outcomes. Extensive preformulation studies were conducted to characterize ondansetron hydrochloride and establish drug-excipient compatibility using FTIR and DSC. Systematic screening of film-forming polymers (HPMC E5, HPMC E15, PVA, PVP K30) and plasticizers (glycerin, propylene glycol, PEG 400) was performed. Twelve formulations (F1-F12) were prepared by solvent casting method with variations in polymer type, polymer concentration (40-70 mg per 4 cm² film), and incorporation of PVP K30 as disintegration enhancer. Films were evaluated for physical appearance, thickness uniformity, weight variation, folding endurance, surface pH, moisture content, drug content uniformity, mechanical properties (tensile strength, elongation at break, Young's modulus), disintegration time, and dissolution profile. The optimized formulation was subjected to advanced characterization (FTIR, DSC, XRD, SEM) and stability studies as per ICH guidelines under accelerated (40°C/75% RH) and long-term (25°C/60% RH) conditions.

Ondansetron, Oral fast dissolving films, HPMC, Solvent casting, Rapid disintegration, Enhanced dissolution, Patient compliance, Antiemetic therapy.