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首页> 美国卫生研究院文献>AAPS PharmSciTech >Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets
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Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets

机译：聚合物载体体系掩盖盐酸恩丹西酮的味道及速崩片的配方

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The purpose of this research was to mask the intensely bitter taste of ondansetron HCl and to formulate a rapiddisintegrating tablet (RDT) of the taste-maske drug. Taste masking was done by complexing ondansetron HCl with aminoalkyl methacrylate copolymer (Eudragit EPO) in different ratios by the precipitation method. Drug-polymer complexes (DPCs) were tested for drug content, in vitro taste in simulated salivary fluid (SSF) of pH 6.2, and molecular property. Complex that did not release drug in SSF was considered taste-masked and selected for formulation RDTs. The complex with drug-polymer ratio of 8∶2 did not show drug release in SSF; therefore, it was selected. The properties of tablets such as tensile strength, wetting time, water absorption ratio, in vitro disintegration time, and disintegration in the oral cavity were investigated to elucidate the wetting and disintegration characteristics of tablets. Polyplasdone XL-10 7% wt/wt gave the minimum disintegration time. Tablets of batch F4 containing spray-dried mannitol and microcrystalline cellulose in the ratio 1∶1 and 7% wt/wt Polyplasdone XL-10 showed faster disintegration, within 12.5 seconds, than the marketed tablet (112 seconds). Good correlation between in vitro disintegration behavior and in the oral cavity was recognized. Taste evaluation of RDT in human volunteers revealed considerable taste masking with the degree of bitterness below threshold value (0.5) ultimately reaching to 0 within 15 minutes, whereas ondansetron HCl was rated intensely bitter with a score of 3 for 10 minutes. Tablets of batch F4 also revealed rapid drug release (t90, 60 seconds) in SGF compared with marketed formulation (t90, 240 seconds;P<.01). Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated tablets in the oral cavity.
机译：这项研究的目的是掩盖盐酸恩丹西酮的强烈苦味，并配制掩味药物的快速崩解片（RDT）。通过沉淀法将盐酸恩丹西酮与甲基丙烯酸氨基烷基酯共聚物（Eudragit EPO）以不同比例络合来掩盖味道。测试了药物-聚合物复合物（DPC）的药物含量，在pH 6.2的模拟唾液（SSF）中的体外味道以及分子特性。在SSF中不释放药物的复合物被认为具有掩味作用，并被选择用于RDT。药物-聚合物比为8∶2的复合物在SSF中未显示出药物释放。因此，它被选中。研究片剂的特性，例如抗张强度，润湿时间，吸水率，体外崩解时间和在口腔中崩解，以阐明片剂的润湿和崩解特性。 Polyplasdone XL-10 7％wt / wt给出了最短的崩解时间。含有喷雾干燥的甘露醇和微晶纤维素的比例为1∶1和7％wt / wt的Polyplasdone XL-10的批次F4片剂比市售片剂（112秒）在12.5秒内显示出更快的崩解。公认的体外崩解行为与口腔内的良好相关性。在人类志愿者中对RDT的味道评估显示，掩盖了相当多的味道，其苦味程度低于阈值（0.5），最终在15分钟内达到0，而恩丹西酮盐酸盐的苦味等级为3，评分为10分钟。与市售制剂（t90，240秒； P ＜0.01）相比，批次F4的片剂还显示出SGF中的快速药物释放（t90，60秒）。因此，结果最终证明成功掩盖了味道，并且使配制的片剂在口腔中迅速崩解。

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