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响应面法在富马酸比索洛尔缓释骨架片处方设计与优化中的应用

Use of response surface methodology in the formulation and optimization of bisoprolol fumarate matrix tablets for sustained drug release.

作者信息

Malakar Jadupati, Nayak Amit Kumar, Goswami Soumita

机构信息

Department of Pharmaceutics, Bengal College of Pharmaceutical Sciences and Research, Durgapur, West Bengal 713212, India.

出版信息

ISRN Pharm. 2012;2012:730624. doi: 10.5402/2012/730624. Epub 2012 Dec 10.

Abstract

The aim of this investigation was to develop and optimize bisoprolol fumarate matrix tablets for sustained release application by response surface methodology based on 2(3) factorial design. The effects of the amounts of calcium alginate, HPMC K4M, and Carbopol 943 in bisoprolol fumarate matrix tablets on the properties of bisoprolol fumarate sustained release matrix tablets like drug release and hardness were analyzed and optimized. The observed responses were coincided well with the predicted values by the experimental design. The optimized bisoprolol fumarate matrix tablets showed prolonged sustained release of bisoprolol fumarate over 6 hours. These matrix tablets followed the first-order model with anomalous (non-Fickian) diffusion mechanism.

摘要

本研究的目的是通过基于2(3)析因设计的响应面法,开发并优化富马酸比索洛尔缓释片。分析并优化了富马酸比索洛尔骨架片中海藻酸钙、羟丙甲纤维素K4M和卡波姆943的用量对富马酸比索洛尔缓释骨架片药物释放和硬度等性质的影响。观察到的响应与实验设计的预测值吻合良好。优化后的富马酸比索洛尔骨架片显示富马酸比索洛尔在6小时内持续缓释。这些骨架片遵循具有非菲克扩散机制的一级模型。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5f/3529867/3949365e2a33/ISRN.PHARMACEUTICS2012-730624.sch.001.jpg

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