Formulation Development and Evaluation of Biodegradable Oral Thin Films for the Delivery of Ondansetron

Abstract

Ondansetron, a selective 5-HT₃ receptor antagonist, is commonly used to prevent and treat nausea and vomiting. Conventional oral formulations face drawbacks such as first-pass metabolism and delayed onset of action. To address these issues, biodegradable oral thin films (OTFs) were developed using hydroxypropyl methylcellulose (HPMC) and sodium alginate via the solvent casting method. The films were evaluated for thickness, disintegration time, tensile strength, folding endurance, and drug content uniformity. Results showed film thickness ranged from 0.18 mm to 0.26 mm, and disintegration times varied between 18 to 38 seconds, ensuring rapid onset. Drug content ranged from 96.2% to 102.5%, with the optimized batch (F4) showing 98.6 ± 1.2%. In vitro dissolution studies in phosphate buffer (pH 6.8) using a USP Type II paddle apparatus revealed over 90% of the drug was released within 3 minutes and complete release (~99.5%) by 5 minutes. The F4 formulation exhibited the most efficient release profile (93.8% in 5 minutes). Drug release followed the Higuchi model, indicating diffusion-controlled kinetics, consistent with the hydrophilic polymer matrix. These findings suggest that biodegradable OTFs offer a patient-friendly and effective alternative for Ondansetron delivery, especially suitable for pediatric and geriatric populations requiring rapid and easy administration.