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INFLUENCE OF POLYMER AND BINDER ON EXTENDED-RELEASE ONDANSETRON HCL GRANULES INCORPORATED WITHIN A POLYMER MATRIX

PUTRIANA RACHMAWATI *, LUSY NOVIANI, FRANSISCA NOVI MELIANA

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Ondansetron, a 5-HT3 receptor antagonist, is widely used to prevent nausea and vomiting in patients undergoing chemotherapy, radiotherapy, and surgery. However, pediatric dose adjustments often require tablet crushing, which alters the release profile. This study aimed to develop extended-release ondansetron HCl granules to maintain controlled drug release while allowing flexible dosing. Optimization involved varying the polymer’s molecular weight and concentration, as well as the binder concentration. Encapsulated granules were evaluated for physical properties and dissolution profiles over 24 hours. Increasing hydroxypropylmethylcellulose (HPMC) molecular weight reduced the release rate, prolonging drug release. The optimal formula (F3) contained 50% HPMC K100000 and 5% binder, exhibiting good flowability, uniform particle size (850–425 μm), and acceptable loss on drying (5.79%). Dissolution studies confirmed over 95% drug release within 16 hours in aqueous medium, 8 hours in phosphate buffer (pH 6.8), 4 hours in HCl buffer (pH 1.2), and 12 hours in acetate buffer (pH 4.5). The developed formulation ensures prolonged therapeutic efficacy, making it a promising alternative for managing chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV) while allowing dose flexibility.