DEVELOPMENT AND EVALUATION OF SUBLINGUAL ONDANSETRON TABLETS FOR RAPID ANTIEMETIC THERAPY.

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Abstract
Objective: This study was undertaken to design a rapidly disintegrating sublingual tablet of ondansetron hydrochloride intended to provide prompt antiemetic action. The formulation approach was aimed at enhancing onset of action, avoiding hepatic first-pass metabolism, and improving administration in patients who experience nausea, vomiting, or difficulty swallowing conventional tablets. Methods: Nine tablet formulations were produced by direct compression using three superdisintegrants, namely crospovidone, croscarmellose sodium, and sodium starch glycolate, at different concentrations. Powder blends were characterized for angle of repose, bulk density, tapped density, Hausner’s ratio, and compressibility index. Finished tablets were evaluated for weight variation, hardness, friability, drug content, wetting time, disintegration time, and dissolution behavior. Compatibility between ondansetron and excipients was assessed by FTIR spectroscopy. Drug release profiles were analyzed using various kinetic models, and the optimized formulation was subjected to accelerated stability testing at 40 ± 2°C and 75 ± 5% RH for three months. Results: All prepared formulations complied with acceptable quality criteria and showed satisfactory mechanical properties. Tablets containing crospovidone demonstrated superior performance, with formulation F5 exhibiting the fastest disintegration (72.33 ± 0.05 s) and nearly complete drug release (99%) within 10 minutes. Release data were best described by the Korsmeyer–Peppas model (R² = 0.996), indicating diffusion-governed drug release. Stability studies confirmed that the optimized formulation retained its physical integrity and dissolution characteristics throughout the study period. Conclusion: The sublingual ondansetron formulation prepared with crospovidone provided rapid tablet breakup and efficient drug release, indicating its suitability as an alternative dosage form for immediate relief of nausea and vomiting. The formulation offers improved convenience, quick therapeutic action, and promising potential for clinical use and large-scale manufacturing

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