材料性质和工艺参数对不同吞吐量压模填充的影响:基于PLS模型的分析分析
L De Souter1, B J Nitert2, R Waeytens3
1Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium.
International journal of pharmaceutics
|June 19, 2024
概括
增加平板压力吞吐量会对粉末模具填充产生负面影响,导致变化. 本研究解释了基于材料特性和工艺设置的模具填充性能,开发了配方开发的预测模型.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学 材料科学 材料科学
背景情况:
- 在旋转压力机上生产平板电脑需要在模具填充过程中复杂的粉末动力学.
- 增加的吞吐量可能会改变粉末的流量,可能会导致诸如平板电脑重量变化,内容均性问题,封装和层等问题.
研究的目的:
- 调查材料性能和工艺设置,包括吞吐量,对小型和大型平板电脑的模具填充性能的影响.
- 开发一种用于平板制造中模具填充变量的预测模型.
主要方法:
- 在不同的吞吐量条件下,模具填充过程中粉末动态的分析.
- 评估药片重量的变化,含量的一致性,封装和分层.
- 材料属性的表征,如密度,多孔性和可压缩性.
- 预测模型的开发和验证.
主要成果:
- 发现更高的吞吐量会对压模填充的可变性产生负面影响,这是由于居住时间缩短和填充分数较低.
- 大小小的平板之间,模具填充机制有很大差异.
- 密度较高,孔隙较小,压缩能力较低,流动性更好的粉末表现出更高的模具填充一致性.
结论:
- 吞吐量是影响平板制造中模具填充变化的关键因素.
- 材料特性在实现一致的模具填充方面发挥着重要作用.
- 开发的模型可以通过预测模具填充的可变性和减少对高通量实验的需求来帮助早期配方开发.
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