药品的连续制造:采用NIR和Raman作为PAT工具的综合方法
Londhe Sachin Bhimrao1, Suraj Kumar1, Ashish K Agrawal1
1Department of Pharmaceutical Engineering and Technology, Indian Institute of Technology (BHU), Varanasi 221005, India.
International journal of pharmaceutics
|December 11, 2025
概括
连续制造 (CM) 与传统的批量制造方法相比,提供了制药生产优势. 使用拉曼和NIR光谱的过程分析技术 (PAT) 可实现实时质量控制和CM过程优化.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 分析化学 分析化学
- 工艺工程的过程工程.
背景情况:
- 由于成本上升和药物开发速度放缓,制药行业面临提高效率的压力.
- 传统的批量生产方法正面临着更具适应性和效率的工艺需求的挑战.
- 连续制造 (CM) 是一个可行的替代方案,提供诸如更快的生产和更强的质量保证等好处.
研究的目的:
- 审查在制药行业的连续制造 (CM) 中拉曼和近红外 (NIR) 光谱的实施情况.
- 突出过程分析技术 (PAT) 在实时过程监控和控制中的作用.
- 总结应用这些光谱技术在制药生产的各个阶段的进展.
主要方法:
- 文献综述侧重于拉曼和NIR光谱在制药CM中的应用.
- 分析过程分析技术 (PAT) 原则是如何与光谱方法集成的.
- 检查涵盖初级,二级和端到端制造操作的研究.
主要成果:
- 拉曼和NIR光谱对于CM中的实时,非破坏性分析至关重要.
- 与这些技术的 PAT 集成可确保产品质量的一致性,通过在过程中进行评估.
- 在使用这些光谱工具的药物物质和产品的CM中观察到显著的进步.
结论:
- 与PAT集成的拉曼和NIR光谱是有效和高质量的制药连续制造的关键推动者.
- 这些技术提供了关键的实时化学和物理见解,优化了过程动态.
- 审查强调了这些光谱方法在现代制药生产中的日益重要和成功应用.
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