Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Eur J Pharm Biopharm. 2012 Jan;80(1):209-16. doi: 10.1016/j.ejpb.2011.09.006. Epub 2011 Sep 17.
In this paper, a structured protocol for powder compression analysis as a test to assess the mechanical properties of particles in a formulation development programme is presented. First, the sequence of classification steps of the protocol is described, and secondly, the protocol is illustrated using compression data of six powders of two model substances, sodium chloride and mannitol. From powder compression data, a set of compression variables are derived, and by using critical values of these variables, the stages expressed during the compression of the powders are identified and the powders are classified into groups with respect to the expression of particle rearrangement, particle fragmentation and particle plastic deformation during compression. It is concluded that the proposed protocol could, in a satisfactorily way, describe and distinguish between the powders regarding their compression behaviour. Hence, the protocol could be a valuable tool for the formulation scientist to comprehensively assess important functionality-related characteristics of drugs and excipients.
本文提出了一种粉末压缩分析的结构化方案，作为评估制剂开发计划中颗粒力学性能的测试方法。首先，描述了方案的分类步骤序列；其次，使用两种模型物质（氯化钠和甘露醇）的六种粉末的压缩数据说明了该方案。从粉末压缩数据中得出了一组压缩变量，并通过使用这些变量的临界值，确定了在粉末压缩过程中表达的阶段，并根据粉末在压缩过程中颗粒重排、颗粒破碎和颗粒塑性变形的表达将粉末分类。结论认为，所提出的方案可以以令人满意的方式描述和区分粉末的压缩行为。因此，该方案可以成为配方科学家全面评估药物和赋形剂重要功能相关特性的有用工具。
