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一种用于药物片剂压缩特性描述的简化模型结构。

A Simplified Model Structure for Compression Characterization of Pharmaceutical Tablets.

机构信息

Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen Ø, Denmark.

出版信息

J Pharm Sci. 2022 Nov;111(11):3088-3095. doi: 10.1016/j.xphs.2022.07.007. Epub 2022 Jul 12.

Abstract

Despite, or maybe because of, many shortcomings, Heckel's equation is by far the most investigated compressibility model for decades. The somewhat overlooked Gurnham equation is proposed as a more stable and better fitting compressibility model. Combining this equation with a linear model for the strength/pressure relation provides a composite function identical with the often-used Ryshkewitch equation for the relation between strength and porosity. It is thus questioned whether the three-dimensional compression characterization presented in USP monograph 1062 is correct. Substantial errors in computed parameters are revealed with consequences for reproducibility or inter-lab assessments. Elastic recovery is proposed as a more interesting and relevant characteristic in relation to pharmaceutical tablet formulation.

摘要

尽管存在许多缺陷,但 Heckel 方程无疑是几十年来研究最多的压缩性模型。有些被忽视的 Gurnham 方程被提议作为一种更稳定和更好拟合的压缩性模型。将该方程与强度/压力关系的线性模型结合起来,可以提供与经常使用的强度和孔隙率之间关系的 Ryshkewitch 方程相同的复合函数。因此,有人质疑 USP 专论 1062 中提出的三维压缩特性是否正确。计算参数中存在大量误差,这对重现性或实验室间评估产生了影响。弹性恢复被提议作为与药物片剂配方相关的更有趣和更相关的特性。

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