FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF ONDANSETRON USING SUPERDISINTEGRANTS BLENDS AND INCLUSION COMPLEXATION FOR RAPID ANTIEMETIC THERAPY

Abstract

Objective: The present work aimed to design and optimize a fast dissolving tablet (FDT) of ondansetron hydrochloride (4 mg) to achieve rapid disintegration, acceptable taste masking, and prompt antiemetic action, thereby enhancing patient compliance in paediatric, geriatric, and dysphagic populations. Methods: Nine formulations (F1–F9) were prepared by direct compression following inclusion complexation of the drug with β-cyclodextrin via the kneading method. The formulations employed varying levels of crospovidone and croscarmellose sodium as binary superdisintegrant blends. Preformulation studies, including Fourier-transform infrared (FTIR) spectroscopy, were conducted to assess drug–excipient compatibility and inclusion complexation. Micromeritic properties of lubricated blends and physicomechanical characteristics of compressed tablets were evaluated. Disintegration time, wetting time, water absorption ratio, and taste masking were assessed. In vitro drug release was performed in pH 6.8 phosphate buffer using a USP Type II dissolution apparatus at 37 ± 0.5 °C and 50 rpm. Dissolution kinetics were analysed by zero-order, first-order, Higuchi, Korsmeyer–Peppas, and Hixson–Crowell models. Accelerated stability studies were conducted as per ICH Q1A(R2) guidelines. Results: Compatibility studies confirmed the absence of physicochemical interactions between ondansetron and the selected excipients; FTIR spectra of the inclusion complex suggested effective drug entrapment within the β-cyclodextrin cavity. Among all batches, formulation F5, containing 4% w/w crospovidone and 2% w/w croscarmellose sodium, exhibited the most desirable performance: a disintegration time of 18 ± 1 s, wetting time of 15 ± 1 s, and cumulative drug release of 98.5 ± 1.0 % within 10 min. The release followed first-order kinetics most closely (R² = 0.965) with a Fickian diffusion mechanism (release exponent, n = 0.428; R² = 0.996). All formulations complied with pharmacopoeial limits for weight variation, hardness, friability, and content uniformity. Accelerated stability testing (40 ± 2 °C / 75 ± 5% RH, 90 days) demonstrated no significant change in drug content, disintegration time, or release behaviour; the similarity factor (f₂) remained above 82. Conclusion: The optimized fast dissolving tablet achieved rapid disintegration and near-complete drug release within 10 min, alongside successful taste masking, presenting a viable platform for the rapid management of chemotherapy-induced and postoperative nausea and vomiting.