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一个合理的层次结构来捕捉原材料属性在制药药物产品开发和制造生命周期中的变化

Stephen L Conway¹, Kenneth J Rosenberg², Sutthilug Sotthivirat³

¹Center for Materials Science and Engineering, MMD, Merck & Co., Inc., Rahway, NJ, USA; Current affiliation Packaging Commercialization, MMD Merck & Co., Inc., Rahway, NJ, USA.

Journal of pharmaceutical sciences

|October 14, 2023

概括

评估药物产品稳定性的新框架使用原材料 (RM) 变化的层次结构来生成持久数据. 这种方法提高了对属性-性能关系的理解,超越了历史的设计质量 (QbD) 限制.

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:

评估原材料 (RM) 的变化对于制药产品的配方和制造稳定性至关重要.
现有的方法,如设计质量 (QbD),在商业制造和生命周期管理方面存在局限性.
小开发数据集难以预测现实世界的变化和属性-性能关系.

研究的目的:

为探索RM变异及其对药物产品稳定性的影响提出一个整体框架.
通过常见的故障模式挑战拟议的框架,并证明其有效性.
与历史的QbD方法相比,提供一种更持久和更有价值的稳定性评估方法.

主要方法:

审查目前的实践,以探索药物开发中的RM变化.
开发一个基于RM变化的层次结构的整体框架.
在材料节约实验中将更高级的RM变化纳入扰动.
使用案例研究来说明框架的应用和好处.

主要成果:

结合更高级的RM变体的材料节约实验产生了强大而持久的强度数据.
拟议的框架有效地挑战了常见的故障模式.
案例研究表明,该框架能够避免历史QbD方法的陷.

结论:

拟议的整体框架提供了一种优越的方法来评估药物产品对RM变异的稳定性.
这种方法为初始开发和生命周期管理提供了有价值的数据,包括评估变化.
在制定和流程开发中将稳定性数据置于上下文中,是成功应用的关键.

关键词:

药物与辅助剂的相互作用辅助物质 (s) 是一个辅助物质.配方配方是一种配方.物理特征物理特征过程稳固性过程稳固性通过设计的质量 (QbD)

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