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通过aQbD方法进行歧视性溶解方法开发

Hongbo Chen¹, Rui Wang², John-David McElderry³

¹Analytical Development, Biogen Inc., Cambridge, Massachusetts, 02142, USA. hongbo.chen@biogen.com.

AAPS PharmSciTech

|December 8, 2023

概括

使用分析设计质量 (aQbD) 的新两阶段工作流优化了溶解方法的开发,并展示了歧视能力. 这种方法涉及方法可操作设计区域 (MODR) 和配方歧视相关性,确保了强大的和科学指导的溶解测试.

科学领域:

制药科学制药科学
分析化学分析化学
药物开发药物开发

背景情况:

传统的一次性溶解方法开发效率低下,可能无法获得最佳结果.
证明溶解方法的歧视力对于确保产品质量和监管合规性至关重要.
设计时分析质量 (aQbD) 为方法开发和验证提供了一种系统的方法.

研究的目的:

开发和介绍一种新的两阶段工作流程,用于溶解方法开发和歧视分析.
整合分析设计质量 (aQbD) 原则,以实现强大高效的溶解方法优化.
建立一种策略,以证明溶解方法的歧视能力.

主要方法:

实施了两阶段的工作流程,首先是溶解方法的开发,然后是歧视分析.
第一个阶段涉及使用高风险参数的实验设计 (DoE) 研究来确定方法可操作设计区域 (MODR).
第二阶段使用了配方-歧视相关图策略来评估方法的歧视能力,并定义了方法歧视性设计区域 (MDDR).

主要成果:

通过定义MODR,成功开发了一种最佳溶解方法.
配方-歧视相关图策略有效地证明了该方法的歧视能力.
工作流可视化了配方参数及其相互作用对溶解的影响,有助于方法选择.
确定了MDDR,为稳健的方法性能提供了一个定义的区域.

结论:

拟议的基于aQbD的工作流提供了科学和系统的方法来开发溶解方法.
这种工作流提高了溶解方法的稳定性,并有效地证明了它们的歧视力.
整合MODR和表述-歧视相关图策略,与传统方法相比,具有显著的优势.

关键词:

从设计开始的分析质量.歧视性溶解方法的方法.方法歧视性设计区域方法可操作的设计区域.

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