盐酸二甲双胍缓释基质片的响应面优化:一些亲水聚合物对释放的影响

ISRN Pharmaceutics Pub Date : 2012-01-01 Epub Date: 2012-09-04 DOI:10.5402/2012/364261
Amitava Roy, Kalpana Roy, Sarbani Roy, Jyotirmoy Deb, Amitava Ghosh, Kazi Asraf Ali
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引用次数: 0

摘要

本研究旨在利用湿法制粒技术开发盐酸二甲双胍的模型缓释基质片剂配方。在本研究中,采用了制剂设计来统计优化盐酸二甲双胍片剂在不同药物与聚合物比率下的不同参数,使用了 K4M 和 K100M 两种等级的聚合物羟丙基甲基纤维素作为两个自变量,而研究的因变量为从溶出动力学数据中获得的 X(60)、X(120)、T(50)、T(90)、n 和 b 值。体外药物释放研究是在模拟肠液中进行的。药物释放呈零阶动力学。对颗粒和片剂的正常物理、形态和分析参数进行了测试,结果均符合要求。红外光谱显示,药物与聚合物之间没有明显的相互作用。研究发现,在增加羟丙基甲基纤维素 K100M 浓度和降低羟丙基甲基纤维素 K4M 浓度的最佳条件下,制剂的释放曲线非常优美,而且在统计学上具有显著性和通用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Response surface optimization of sustained release metformin-hydrochloride matrix tablets: influence of some hydrophillic polymers on the release.

The aim of the present work was designed to develop a model-sustained release matrix tablet formulation for Metformin hydrochloride using wet granulation technique. In the present study the formulation design was employed to statistically optimize different parameters of Metformin hydrochloride tablets at different drug-to-polymer ratios employing polymers Hydroxypropyl methylcellulose of two grades K4M and K100M as two independent variables whereas the dependent variables studied were X(60), X(120), T(50), T(90), n, and b values obtained from dissolution kinetics data. The in vitro drug release studies were carried out at simulated intestinal fluids, and the release showed a non-Fickian anomalous transport mechanism. The drug release was found to reveal zero order kinetics. The granules and the tablets were tested for their normal physical, morphological, and analytical parameters and were found to be within the satisfactory levels. There were no significant drug-polymer interactions as revealed by infrared spectra. It has been found out that on an optimum increased Hydroxypropyl methylcellulose K100M concentration and decreased Hydroxypropyl methylcellulose K4M concentration the formulations were elegant in terms of their release profiles and were found to be statistically significant and generable.

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