使用破裂模式概率内核来预测多个颗粒属性的多维人口平衡模型开发
Ashley Dan1, Haresh Vaswani1, Alice Šimonová2
1Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.
Pharmaceutical development and technology
|July 6, 2023
概括
这项研究开发了削工艺的预测模型,准确预测颗粒质量属性,如API含量和孔隙性. 该模型增强了对加工条件如何影响最终药物产品质量的理解.
科学领域:
- 制药工程 制药工程
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
背景情况:
- 削显著影响了颗粒大小以外的关键颗粒属性,包括API含量和孔隙性.
- 这些属性直接影响最终药物产品的质量和性能.
- 预测削对颗粒质量的影响对于强大的制药制造至关重要.
研究的目的:
- 开发和验证一个预测模型,用于Comil削过程.
- 将颗粒质量属性 (API 含量,多孔性) 纳入建模框架.
- 在削过程中动态预测断裂模式.
主要方法:
- 开发一种混合人口平衡模型 (PBM) 用于COMIL模拟.
- 使用实验数据验证PBM,实现R2>0.9.
- 增加了PBM的维度,包括API含量和多孔性.
- 实现破裂模式概率内核用于磨损和冲击预测.
主要成果:
- 开发的PBM准确地预测了颗粒大小分布和颗粒质量属性.
- 成功生成了API内容和孔隙性的模型预测.
- 断裂模式内核基于过程条件动态预测了磨损和冲击概率.
结论:
- 混合PBM提供了一个强大的工具,用于理解和预测削对颗粒质量的影响.
- 该模型能够考虑API含量和多孔性,从而提高其在药物配方中的适用性.
- 动态预测断裂模式可以提高对削过程的机械学理解.
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