积极居住时间分布方法用于确定制药连续制造中关键材料属性的低风险设定点
Pasindu Herath Pathirannahalage1, Ayumu Nabetani1, Shota Kato1
1Department of Informatics, Kyoto University, Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501, Japan.
International journal of pharmaceutics
|July 14, 2025
概括
主动居住时间分布 (P-RTD) 方法确保在连续制药制造过程中,关键材料属性保持在设计空间内. 这种新的方法在模拟中证明了在所有测试条件中有效.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 化学工程是化学工程的重要组成部分.
- 过程控制 过程控制
背景情况:
- 制药行业越来越多地采用连续制造来提高生产率.
- 连续制造中的综合工艺对质量保证构成挑战.
- 在设计空间 (DS) 中保持关键材料属性 (CMA) 对于确保药物产品质量至关重要.
研究的目的:
- 引入和评估用于连续制药制造的新型控制方法.
- 在复杂的集成流程中,应对在DS中保持CMA的挑战.
- 确定CMA反控制的最佳设置点.
主要方法:
- 开发主动居住时间分布 (P-RTD) 方法.
- 使用居住时间分布 (RTD) 函数计算有效的CMA.
- 连续干颗粒线的控制模拟,将P-RTD与其他三种方法进行比较.
- 在不同的条件下进行的模拟,包括不同的CMA关系和过程滞后时间.
主要成果:
- 在所有模拟条件下,P-RTD方法成功地保持了设计空间内的CMA.
- 与其他三种方法的比较表明,P-RTD方法的性能优越.
- 通过各种过程复杂性和延迟时间,证实了P-RTD方法的稳定性.
结论:
- 在连续制药制造中,P-RTD方法是高效的质量保证策略.
- 基于RTD函数的预测控制提供了一种可靠的方式来确定CMA的设定点.
- 通过将CMA保持在设计空间内,P-RTD方法确保了一致的产品质量,在模拟中优于现有方法.
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