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一种节省材料的方法,用于评估粉末变形特性,该方法使用在单个压缩-减压循环过程中收集的数据。

A material-sparing method for assessment of powder deformation characteristics using data collected during a single compression-decompression cycle.

机构信息

Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, Pennsylvania, 15282.

出版信息

J Pharm Sci. 2013 Oct;102(10):3687-93. doi: 10.1002/jps.23676. Epub 2013 Jul 29.

DOI:10.1002/jps.23676
PMID:23897398
Abstract

Compressibility profiles, or functions of solid fraction versus applied pressure, are used to provide insight into the fundamental mechanical behavior of powders during compaction. These functions, collected during compression (in-die) or post ejection (out-of-die), indicate the amount of pressure that a given powder formulation requires to be compressed to a given density or thickness. To take advantage of the benefits offered by both methods, the data collected in-die during a single compression-decompression cycle will be used to generate the equivalent of a complete out-of-die compressibility profile that has been corrected for both elastic and viscoelastic recovery of the powder. This method has been found to be both a precise and accurate means of evaluating out-of-die compressibility for four common tableting excipients. Using this method, a comprehensive characterization of powder compaction behavior, specifically in relation to plastic/brittle, elastic and viscoelastic deformation, can be obtained. Not only is the method computationally simple, but it is also material-sparing. The ability to characterize powder compressibility using this approach can improve productivity and streamline tablet development studies.

摘要

压缩性曲线,或者说固体分数与施加压力的函数,用于深入了解粉末在压缩过程中的基本机械行为。这些功能是在压缩过程中(模内)或推出后(模外)收集的,表明给定粉末配方在压缩到给定密度或厚度时所需的压力量。为了充分利用这两种方法的优势,将在单个压缩-减压循环过程中模内收集的数据用于生成等效的完整模外压缩性曲线,该曲线已针对粉末的弹性和粘弹性恢复进行了校正。已经发现,该方法是评估四种常见压片赋形剂模外压缩性的一种精确而准确的方法。使用这种方法,可以全面描述粉末的压缩行为,特别是与塑性/脆性、弹性和粘弹性变形有关的行为。该方法不仅计算简单,而且节省材料。使用这种方法来表征粉末的可压缩性可以提高生产效率并简化片剂开发研究。

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