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使用偏心式压片机和旋转式压片机压制的片剂裂片情况比较。

Comparison of the halving of tablets prepared with eccentric and rotary tablet presses.

作者信息

Sovány T, Kása P, Pintye-Hódi K

机构信息

Department of Pharmaceutical Technology, University of Szeged, Eötvös str. 6, Szeged, 6720, Hungary.

出版信息

AAPS PharmSciTech. 2009;10(2):430-6. doi: 10.1208/s12249-009-9225-2. Epub 2009 Apr 21.

Abstract

The aim of this study was to compare the densification of powder mixtures on eccentric and rotary tablet presses and to establish relationships with the halving properties of the resulting scored tablets. This is an important problem because the recent guidelines of EU require verification of the equal masses of tablet halves. The models of Walker, Heckel, and Kawakita were used to describe the powder densification on the two machines. The calculated parameters revealed that the shorter compression cycle of rotary machines results in poorer densification and lower tablet hardness at a given compression force. This is manifested in poorer halving properties, which are influenced mainly by the hardness. Better densification improves the halving even at lower tablet hardness. This demonstrates that these parameters can be good predictors of tablet halving properties.

摘要

本研究的目的是比较偏心式和旋转式压片机上粉末混合物的致密化情况,并建立与所得刻痕片剂的对半切割性能之间的关系。这是一个重要问题,因为欧盟最近的指南要求验证片剂两半的质量相等。使用沃克(Walker)、赫克尔(Heckel)和川北(Kawakita)模型来描述两种机器上的粉末致密化情况。计算得出的参数表明,在给定的压力下,旋转式机器较短的压缩周期会导致致密化程度较差和片剂硬度较低。这表现为对半切割性能较差,而对半切割性能主要受硬度影响。即使在较低的片剂硬度下,更好的致密化也能改善对半切割性能。这表明这些参数可以很好地预测片剂的对半切割性能。

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