使用直线测量和统计分析来预测使用Styl'One压缩模拟器压缩的平板电脑性能:一项高剪切湿颗粒研究
Issa Munu1, Andrei L Nicusan2, Jason Crooks3
1School of Chemical Engineering, The University of Birmingham, Edgbaston, Birmingham B15 2TT, UK; GSK Global Supply Chain, Priory St, Ware SG12 0DJ, UK.
International journal of pharmaceutics
|December 18, 2024
概括
这项研究将高剪湿颗粒处理 (HSWG) 过程中的直线测量与颗粒和平板电脑的性能联系起来. 一个对平板电脑抗拉强度的预测模型在不同的压缩模拟器中被证明是有效的,这表明了工业平板电脑制造的可扩展性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
- 颗粒化科学 颗粒化科学
背景情况:
- 高剪切湿颗粒 (HSWG) 对于药片制造至关重要,增强粉末的特性,防止分离.
- 在线过程分析技术 (PAT) 对于实时监测和控制复杂的颗粒加工过程至关重要.
研究的目的:
- 为了确定Lenterra在线测量和由此产生的颗粒和药片特性之间的关系.
- 为了研究HSWG期间颗粒生长机制.
- 使用PAT数据开发一款平板电脑抗拉强度的预测模型.
主要方法:
- 使用Styl'One Evolution压缩模拟器生产平板电脑,模仿工业旋转平板电脑压力机.
- 采用Lenterra在线测量来捕获粒子动态.
- 开发了一个基于Gamlen平板印刷机数据的预测模型.
主要成果:
- 确定了特定于研究条件的诱导颗粒生长机制.
- 该预测模型在应用于来自不同压缩模拟器 (Styl'One Evolution) 的数据时,实现了高精度 (R2=0.9535,RMSE=0.4040 MPa).
- 证明了模型能够预测平板电脑的抗拉强度,而不管使用的压缩机.
结论:
- 开发的模型显示,在不同的压缩设备中,平板电脑的抗拉强度具有很高的可预测性.
- 结果表明,该模型在工业规模的平板电脑制造中具有很大的应用潜力.
- 这项研究促进了对可扩展制药生产的颗粒化工艺的理解和监测.
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