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在固体剂型中检测晶体缺失,使用在线太赫兹工艺分析技术

Chi Ki Leung¹, Lisa Kuchler², J Axel Zeitler¹

¹Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, Cambridge, CB3 0AS, United Kingdom.

International journal of pharmaceutics

|December 10, 2025

概括

太赫兹时域光谱 (THz-TDS) 是一种新工具,可以确保无形固体分散 (ASD) 缺乏晶体性. 这种非破坏性方法快速,可靠,适合药品质量控制.

科学领域:

制药技术制药技术制药技术
频谱学是一种光谱学.
材料科学材料科学材料科学

背景情况:

无形固体分散 (ASDs) 提高了药物的溶解性,但易于再结晶,使得缺乏结晶性成为一个关键的质量属性.
目前用于监测无形剂量形式的非破坏性光谱方法的应用有限.
确保无形状态对于药物的生物可用性和治疗疗效至关重要.

研究的目的:

建立太赫兹时域光谱 (THz-TDS) 作为一种非破坏性,在线过程分析技术 (PAT),用于检测固体剂型中的结晶性.
开发和验证使用THz-TDS的简单,物理可解释的方法来评估晶度的缺失.
证明THz-TDS的稳定性和实用性,用于无形固体剂量的质量控制.

主要方法:

利用太赫兹时域光谱学 (THz-TDS) 进行无形固体分散 (ASD) 的非破坏性分析.
开发了两种分析方法:缺少声子吸收峰值和吸收系数的比率.
评价了沙布塔摩尔ASD片中的方法作为模型系统,评估了对散射和辅助剂效应的稳定性.

主要成果:

通过两种不同的方法,THz-TDS成功且明确地确定了沙布塔摩尔ASD药片中没有结晶性的缺失.
开发的THz-TDS方法证明了对分散和辅助剂吸收的稳定性.
多种仪器的验证和长期存储证实了THz-TDS方法的可靠性.

结论:

太赫兹时域光谱 (THz-TDS) 是一种实用且强大的在线PAT,用于确认固体剂型中的无形状态.
THz-TDS提供了实时释放测试的可行策略,可以作为多属性PAT.
未来的研究将探索THz-TDS在预测无形固体剂量的溶解时间方面的潜力.

关键词:

没有形态的无形.无形固体的分散性固体.结晶性是指结晶性是指结晶性.过程分析技术过程分析技术实时释放测试实时释放测试萨尔布塔摩尔 (Salbutamol) 是一种太赫兹光谱学是一次特拉赫兹光谱学.

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