Development of Ondansetron Tablets with Advanced Disintegrant Technology for Rapid Release and Improved Pharmacokinetics

Abstract

Ondansetron hydrochloride (ONH) is a potent antiemetic drug commonly used for managing nausea and vomiting induced by chemotherapy, radiotherapy, or postoperative conditions. The objective of this study was to develop and evaluate taste-masked fast-dissolving tablets (FDTs) of ONH to enhance patient adherence to treatment. Taste-masked granules of ONH were prepared using a solid dispersion technique, with a solvent evaporation method employed for granulation. The formulation aimed for complete taste masking and minimal drug release in a phosphate buffer (pH 6.8), achieved with a drug-to-polymer ratio of 1:2. Four formulations were selected based on pre-formulation testing and then compressed into FDTs for further evaluation. The tablets were analyzed for drug content uniformity, in-vitro disintegration time, wetting time, in-vivo dissolution profile, and the release rate of the drug. Among all the formulations, F8, which incorporated Caitin sodium as a superdisintegrant, exhibited the fastest drug release, outperforming the pure drug in terms of release speed. The time for 50% drug release (T50) and the drug release efficiency (DE 30%) for formulation F8 were determined to be 7 minutes and 73.5%, respectively, demonstrating its potential as a rapid-release tablet suitable for improving therapeutic outcomes.