Bhoyar Pk, Biyani Dm, Umekar Mj
S.K.B. College of Pharmacy, New Kamptee, Dist. Nagpur, Maharashtra, India.
J Young Pharm. 2010 Jul;2(3):240-6. doi: 10.4103/0975-1483.66796.
Ondansetron hydrochloride is an intensely bitter antiemetic drug used to treat nausea and vomiting following chemotherapy. The purpose of the present work was to mask the taste of ondansetron hydrochloride and to formulate its patient-friendly dosage form. Complexation technique using indion 234 (polycyclic potassium with carboxylic functionality) and an ion-exchange resin was used to mask the bitter taste and then the taste-masked drug was formulated into an orodispersible tablet (ODT). The drug loading onto the ion-exchange resin was optimized for mixing time, activation, effect of pH, mode of mixing, ratio of drug to resin and temperature. The resinate was evaluated for taste masking and characterized by X-ray diffraction study and infrared spectroscopy. ODTs were formulated using the drug-resin complex. The developed tablets were evaluated for hardness, friability, drug content, weight variation, content uniformity, friability, water absorption ratio, in vitro and in vivo disintegration time and in vitro drug release. The tablets disintegrated in vitro and in vivo within 24 and 27 s, respectively. Drug release from the tablet was completed within 2 min. The obtained results revealed that ondansetron HCl has been successfully taste masked and formulated into an ODT as a suitable alternative to the conventional tablets.
盐酸昂丹司琼是一种苦味强烈的止吐药物，用于治疗化疗后出现的恶心和呕吐。本研究的目的是掩盖盐酸昂丹司琼的味道，并制备对患者友好的剂型。采用使用Indion 234（具有羧基官能团的多环钾盐）和离子交换树脂的络合技术来掩盖苦味，然后将掩味后的药物制成口腔崩解片（ODT）。对离子交换树脂上的载药量进行了优化，考察了混合时间、活化、pH值的影响、混合方式、药物与树脂的比例以及温度等因素。对树脂酸盐进行了掩味评价，并通过X射线衍射研究和红外光谱进行了表征。使用药物-树脂复合物制备了口腔崩解片。对所制备的片剂进行了硬度、脆碎度、药物含量、重量差异、含量均匀度、脆碎度、吸水率、体外和体内崩解时间以及体外药物释放等方面的评价。该片剂在体外和体内分别在24秒和27秒内崩解。片剂在2分钟内完成药物释放。所得结果表明，盐酸昂丹司琼已成功掩味，并制成口腔崩解片，作为传统片剂的合适替代品。
