Kuppuswamy R, Anderson S R, Augsburger L L, Hoag S W
Pharmacia Corporation, Skokie, IL, USA.
AAPS PharmSci. 2001;3(1):E5. doi: 10.1208/ps030105.
The purpose of this study was to predict the capping tendencies of pharmaceutical powders by creating indentation fracture on compacts. Three sets of binary mixtures containing different concentrations of each ingredient were used in the study. The binary mixtures were chosen to represent plastic-plastic, plastic-brittle, and brittle-brittle combination of materials. The mixtures were tableted at different pressures and speeds on Prester, a tablet press simulator. These mixtures were also compacted on the Instron Universal Testing Machine 4502. Static indentation tests were done on these compacts at different depths until surface cracking and chipping were observed. The extent of surface cracking and chipping was observed from light microscope and scanning electron microscope images. A rank order correlation was observed between lamination susceptibility and the depth at which indentation failure occurred. It was concluded that indentation fracture tests could provide a useful estimate of lamination properties of pharmaceutical powders.
本研究的目的是通过在压片上产生压痕断裂来预测药物粉末的压盖倾向。研究中使用了三组含有不同浓度各成分的二元混合物。选择二元混合物来代表材料的塑性-塑性、塑性-脆性和脆性-脆性组合。这些混合物在压片机模拟器Prester上以不同压力和速度压片。这些混合物也在英斯特朗万能材料试验机4502上进行压制。在这些压片上进行不同深度的静态压痕试验，直到观察到表面开裂和剥落。从光学显微镜和扫描电子显微镜图像观察表面开裂和剥落的程度。观察到分层敏感性与压痕失效发生深度之间存在等级相关。得出结论，压痕断裂试验可以为药物粉末的分层性质提供有用的估计。
