Vol. 2, Issue 1, Part A (2025)

Background: Ondansetron hydrochloride, a potent 5-HT₃ receptor antagonist, is widely used for the management of chemotherapy- and postoperative-induced nausea and vomiting. However, its short half-life and extensive first-pass metabolism limit oral bioavailability and therapeutic efficiency. To overcome these limitations, this study aimed to develop and characterize mucoadhesive buccal films for controlled delivery of ondansetron hydrochloride.
Methods: Buccal films were formulated using the solvent casting method with varying polymer compositions of hydroxypropyl methylcellulose (HPMC), sodium carboxymethyl cellulose (NaCMC), and chitosan. Polyethylene glycol-400 served as a plasticizer, and citric acid was used to maintain suitable pH and enhance solubility. The prepared films were evaluated for physicochemical parameters, mucoadhesive strength, swelling index, In vitro drug release, and ex vivo permeation across porcine buccal mucosa. Statistical analysis, including one-way ANOVA, was applied to compare formulation performance, and release kinetics were analyzed using mathematical models.
Results: All films exhibited uniform thickness (0.18-0.21 mm), neutral surface pH (6.3-6.5), and satisfactory mechanical strength. The optimized formulation (F4), containing a blend of HPMC:NaCMC:Chitosan (2:1:1), showed the highest mucoadhesive strength (32.5±1.6 g), longest In vitro residence time (182±12 min), and moderate swelling (62.7±4.3%). In vitro release studies demonstrated controlled drug release up to 8 h, with approximately 90% cumulative release for F4, following Korsmeyer-Peppas kinetics (R² = 0.988). Ex vivo permeation studies revealed improved drug flux and permeation coefficient for the optimized film compared to single-polymer formulations.
Conclusion: The study successfully developed a stable, flexible, and effective mucoadhesive buccal film of ondansetron hydrochloride capable of providing sustained drug release, enhanced mucosal residence, and improved permeation. This delivery approach offers a promising, patient-friendly alternative for managing nausea and vomiting, particularly in patients who have difficulty swallowing or require rapid onset of action. The findings highlight the clinical potential of buccal films as a non-invasive and controlled-release system for ondansetron, warranting further in vivo and stability evaluations for therapeutic translation.