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探索原材料特性对连续双螺丝湿颗粒制造能力的影响
Michiel Peeters1, Ana Alejandra Barrera Jiménez2, Kensaku Matsunami2
1Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Oost-Vlaanderen, Belgium.
International journal of pharmaceutics
|September 11, 2023
概括
这项研究开发了使用部分最小平方 (PLS) 进行双螺丝湿颗粒 (TSWG) 的预测模型. 这些模型将原材料特性与最佳的液体/固体比率和颗粒特性联系起来,有助于开发新的活性药物成分 (API).
科学领域:
- 制药科学 制药科学
- 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:
- 双螺丝湿颗粒 (TSWG) 是一种新兴的连续制造技术.
- 对于原材料特性如何影响TSWG可加工性的理解有限.
- 缺乏预测模型阻碍了TSWG新药活性成分 (API) 过程的开发.
研究的目的:
- 开发双螺丝湿颗粒 (TSWG) 处理能力的预测模型.
- 建立材料属性和最佳液体/固体 (L/S) 比率之间的关系.
- 根据初始材料特性预测颗粒的大小和脆性等颗粒属性.
主要方法:
- 开发了四种部分最小平方 (PLS) 模型.
- 模型基于初始材料特性来预测适用的L/S比率范围.
- 模型还使用API属性和L/S比率预测了颗粒大小和脆性.
主要成果:
- 与水相关的特性 (可溶性,可湿性,溶解性) 和密度/流量特性显著影响了TSWG的可加工性.
- 开发的PLS模型成功预测了新API的合适L/S比率.
- 实验验证证了模型在定义所需颗粒性质时的适用性.
结论:
- 原材料的特性极大地影响双螺丝湿颗粒 (TSWG) 的加工能力.
- 开发的PLS模型为优化TSWG流程开发提供了宝贵的工具.
- 这些模型可以在开发新API的流程时减少实验工作量.
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