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冲压黏附性对压缩压力的依赖性——颗粒可变形性和片剂拉伸强度的作用。

Dependence of Punch Sticking on Compaction Pressure-Roles of Particle Deformability and Tablet Tensile Strength.

机构信息

Department of Pharmaceutics, Pharmaceutical Materials Science and Engineering Laboratory, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota 55455.

Pfizer Worldwide Research & Development, Sandwich, UK.

出版信息

J Pharm Sci. 2017 Aug;106(8):2060-2067. doi: 10.1016/j.xphs.2017.04.059. Epub 2017 May 4.

Abstract

Punch sticking is a complex phenomenon influenced primarily by particle size, tooling surface roughness, tooling design, and tooling construction material. When particle and environmental factors are controlled, compaction pressure has a distinct effect on punch sticking behavior for a given active pharmaceutical ingredient (API). This research focuses on the effect of compaction pressure on punch sticking using 5 compounds with different sticking propensities. The results collectively show that sticking tends to be more problematic under higher compaction pressures and for more ductile compounds. This is attributed to the greater punch surface coverage by the API and the stronger cohesion of API to the existing API layer on the punch.

摘要

冲头粘连是一种复杂的现象,主要受颗粒大小、工具表面粗糙度、工具设计和工具制造材料的影响。当控制颗粒和环境因素时,对于给定的活性药物成分 (API),压缩压力对冲头粘连行为有明显的影响。本研究专注于使用 5 种具有不同粘连倾向的化合物来研究压缩压力对冲头粘连的影响。结果表明,在较高的压缩压力下,更具延展性的化合物更容易出现粘连问题。这归因于 API 对冲头表面的更大覆盖以及 API 与冲头上现有 API 层之间更强的内聚力。

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