阿托伐他汀钙漂浮基质片的研制与评价

S. Hardik, K. Tarachand, Yadav Kailash, Bhatt Chintan, Shah Chainesh, R. Vinod
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引用次数: 2

摘要

本研究旨在制备阿托伐他汀钙的漂浮基质药物传递系统,并评估各种工艺参数,包括浮力研究和体外药物释放研究。十五种配方含有不同比例的聚合物如HPMC K100M、HPMC K15M、乙基纤维素和Carbopol 934P,以及固定数量的气体生成剂如碳酸氢钠、柠檬酸和不同浓度的MCC作为填充剂。采用直接压缩法制备该片剂,所制片剂在释放介质中保持浮力12小时以上。F15批用不同比例的HPMC K4M、HPMC k100m和卡波波尔934P制备的药物在105秒、漂浮滞后时间、总漂浮时间大于18小时、释放时间长达12小时的药物有62.11%存在显著差异,其中延长释放时间可能大于15小时。所有制剂均以扩散为主释放。F15批次也显示稳定的%药物含量,因为它显示60天内按照ICH指南执行没有显着变化。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation, Development and Evaluation of Floating Matrix Tablets of Atorvastatin Calcium
S The present study was aimed to prepare a Floating Matrix drug delivery system for the Atorvastatin calcium, andevaluating the various processing parameters including the buoyancy studies and in vitro drug release studies. Fifteen formulations containing varying proportions of polymers like HPMC K100M, HPMC K15M, Ethyl Cellulose and Carbopol 934P and fixed amount of gasgenerating agent such as Sodium bi carbonate and Citric Acid and also MCC in varying concentration as a bulking agent. The tablets were prepared by direct compression technique and the prepared tablets remained buoyant for more than 12 hrs in therelease medium. Batch F15 prepared with different proportions of HPMC K4M, HPMC K100 M and Carbopol 934P showed significant difference in 105 secs, Floating lag time, Total floating time more than 18 hrs and 62.11% releaseupto 12 hrs of the drug which shows extended release may be more than 15 hrs. All theformulations exhibited diffusion dominant drug release. F15 batch also showed stable in means of % Drug Content as it shows no significant change performed as per ICH guidelines for 60 Days.
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