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Process Systems Enterprise, Hammersmith Grove, London W6 7HA, United Kingdom.
Int J Pharm. 2021 Jan 5;592:119980. doi: 10.1016/j.ijpharm.2020.119980. Epub 2020 Oct 16.
A new approach is proposed to support prediction of tablet tensile strength as a function of both solid fraction (and/or compression pressure) and extent of lubrication by using empirical data to parameterise the model. This is a pre-requisite for simulation of the compaction unit operation where a linkage from tablet press operating parameters and formulation material properties to output tensile strength is required. The approach extends the previously published Kushner and Moore model to allow calculation across a range of solid fractions. The applicability of the approach is supported by testing using formulations with different commonly used pharmaceutical excipients.
提出了一种新方法，通过使用经验数据对模型进行参数化，以支持片剂拉伸强度作为固体分数（和/或压缩压力）和润滑程度的函数的预测。这是模拟压缩单元操作的前提，需要从压片机操作参数和配方材料特性到输出拉伸强度的链接。该方法扩展了之前发表的 Kushner 和 Moore 模型，以允许在一系列固体分数范围内进行计算。该方法的适用性通过使用具有不同常用药物赋形剂的配方进行测试得到支持。
