Formulation and In-Vitro Evaluation of Fast Dissolving Oral Films of Ondansetron Hydrochloride

Abstract

The primary goal of this project was to manufacture ondansetron HCl fast-dissolving oral films to improve patient compliance and the drug’s efficacy. Ondansetron HCl, a specific 5-HT₃ receptor antagonist, with an oral bioavailability of 60% and a half-life of 2-4 hours, rendering robust antiemetic. The FDOFs were created utilizing the solvent casting method using a variety of polymers like HPMC E15, HPMC K4M, PVA, and PEG 400 as plasticizers and sodium starch glycolate as super disintegrants. Citric acid served as a saliva-stimulating agent.

In the present study, numerous evaluation criteria were applied to the nine formulations. Evaluation of the physical properties of ondansetron HCl FSOFs produced satisfactory findings including thickness (0.078±0.022-0.132±0.057 mm), surface pH (6.83±0.057–6.9±1.087), folding endurance (95±5.033-383±3.605), disintegration time (115-168 sec), SI (9.874±1.716-40.569±1.901%), percentage moisture loss and uptake (2.384±1.407- 23.196±1.440% and 5.480±0.278- 29.206±7.453%), percentage elongation (150 -325 % mm²) and tensile strength (0.005-0.03 kg/mm2). The evaluation’s findings suggested that the uniformity of medication content varied between 78% (F6) and 97% (F2). In contrast to other formulations, formulation F2 demonstrated higher drug loading. All developed formulations were submitted to an in-vitro permeation analysis, and formulation F2 demonstrated drug release of 98.04% within 5 minutes.