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首页> 美国卫生研究院文献>ISRN Pharmaceutics >Response Surface Optimization of Sustained Release Metformin-Hydrochloride Matrix Tablets: Influence of Some Hydrophillic Polymers on the Release
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Response Surface Optimization of Sustained Release Metformin-Hydrochloride Matrix Tablets: Influence of Some Hydrophillic Polymers on the Release

机译：缓释二甲双胍-盐酸基质片剂的响应面优化：某些亲水聚合物对释放的影响

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摘要

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 X60, X120, T50, T90, 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.
机译：本工作的目的是设计使用湿法制粒技术开发盐酸二甲双胍的模型缓释基质片剂。在本研究中，采用制剂设计，以统计学上最优化的二甲双胍盐酸盐片剂的不同参数，使用两个等级K4M和K100M的聚合物羟丙基甲基纤维素作为两个自变量，而研究的因变量是X60，X120，从溶解动力学数据获得的T50，T90，n和b值。在模拟的肠液中进行了体外药物释放研究，该释放显示出非费克式异常转运机制。发现药物释放揭示了零级动力学。测试了颗粒和片剂的正常物理，形态和分析参数，发现其处于令人满意的水平内。如红外光谱所示，没有显着的药物-聚合物相互作用。已经发现，在最佳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浓度的条件下，制剂在其释放特性方面是优雅的，并且被发现具有统计学意义和可生产性。

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