在USP装置I,II和III上进行预测溶解建模
Alexander M Kubinski1, Ricardo D Sosa1, Gayathri Shivkumar2
1Product Development, Science & Technology, Operations, AbbVie Inc., North Chicago, IL 60208, United States.
Journal of pharmaceutical sciences
|March 19, 2025
概括
这项研究描述了溶解器件III,开发了一个预测溶解模型 (PDM),可以在USP器件I,II和III上扩展药物释放动力学,从而增强配方开发.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 计算制药学 计算机制药学
背景情况:
- 溶解测试对于口服剂型的体外药物释放特性至关重要.
- 在现有的预测溶解建模 (PDM) 工具中,USP 装置 I 和 II 是常见的.
- 提供更高的激发和多血管能力的USP装置III缺乏PDM的特征物理.
研究的目的:
- 描述溶解装置的运输物理和热力学III.
- 为设备III建立和验证一维预测溶解模型 (PDM).
- 为了使释放动力学能够在USP装置I,II和III之间进行扩展.
主要方法:
- 溶解装置的运输物理和热力学特征 III.
- 一个1-D PDM的开发和验证.
- 校准使用不同度的溶解实验;以侵蚀为基础的配方进行验证.
主要成果:
- 建立了一个经过验证的1-D PDM,成功地通过激发扩大释放动力学.
- 该模型使用任何组合的校准数据预测器件I,II和III中的药物释放.
- 显示了装置III的船舶停留时间分析.
结论:
- 开发的PDM有效地弥合了溶解装置III的知识差距.
- 该模型增强了在多个USP装置中开发固体口服剂型的预测能力.
- 该方法允许在定义的设计空间内对药物释放动力学进行可靠的预测.
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