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首页> 外文期刊>International Journal of Pharmaceutics >Effect of source variation on drug release from HPMC tablets: linear regression modeling for prediction of drug release.
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Effect of source variation on drug release from HPMC tablets: linear regression modeling for prediction of drug release.

机译：来源变化对HPMC片剂药物释放的影响：用于预测药物释放的线性回归模型。

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摘要

The aim of this study was to investigate the effect of source variation of hydroxypropyl methylcellulose (HPMC) raw material on prediction of drug release from HPMC matrix tablets. To achieve this objective, the flow ability (i.e., angle of repose and Carr's compressibility index) and apparent viscosity of HPMC from 3 sources was investigated to differentiate HPMC source variation. The physicochemical properties of drug and manufacturing process were also incorporated to develop the linear regression model for prediction of drug release. Specifically, the in vitro release of 18 formulations was determined according to a 2 x 3 x 3 full factorial design. Further regression analysis provided a quantitative relationship between the response and the studied independent variables. It was found that either apparent viscosity or Carr's compressibility index of HPMC powders combining with solubility and molecular weight of drug had significant impact on the release behavior of drug. The increased drug release was observed when a greater in drug solubility and a decrease in the molecular weight of drug were applied. Most importantly, this study has shown that the HPMC having low viscosity or high compressibility index resulted in an increase of drug release, especially in the case of poorly soluble drugs.
机译：这项研究的目的是研究羟丙基甲基纤维素（HPMC）原料来源变化对预测HPMC基质片剂释放药物的影响。为了实现该目的，研究了来自三种来源的HPMC的流动能力（即休止角和Carr的可压缩性指数）和表观粘度，以区分HPMC来源的变化。还结合了药物的物理化学性质和制造工艺，以开发用于预测药物释放的线性回归模型。具体而言，根据2 x 3 x 3全因子设计确定18种制剂的体外释放。进一步的回归分析提供了响应与研究的独立变量之间的定量关系。发现HPMC粉末的表观粘度或Carr可压缩性指数与药物的溶解度和分子量相结合对药物的释放行为具有显着影响。当施加更大的药物溶解度和降低药物分子量时，观察到药物释放增加。最重要的是，这项研究表明，具有低粘度或高可压缩性指数的HPMC导致药物释放的增加，尤其是在难溶药物的情况下。

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