使用时间域NMR持续监测水友矩阵片的水化行为
Takahiro Tsuji1, Takashi Ono1,2, Hiromu Taguchi2
1Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd.
Chemical & pharmaceutical bulletin
|July 2, 2023
概括
时间域NMR (TD-NMR) 有效监测水友基矩阵片的水分. 这种强大的技术可以区分聚合物行为并预测药物释放,为制药开发提供了宝贵的工具.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 分析化学 分析化学
背景情况:
- 水友性矩阵片被广泛用于控制药物释放.
- 了解平板电脑的水分是预测药物释放概况的关键.
- 传统的水分监测方法可能耗时且信息不足.
研究的目的:
- 评估时间域核磁共振 (TD-NMR) 作为持续监测水友基矩阵平板电池水化的方法.
- 为了描述聚乙烯氧化物 (PEO) 和基甲基纤维素 (HPMC) 矩阵片的水合行为.
- 评估TD-NMR水化数据与体外药物溶解之间的相关性.
主要方法:
- 使用固体回声序的TD-NMR来获得T2放松曲线.
- 使用曲线拟合分析来量化非化核心.
- 模型片 (PEO,HPMC,PEG) 和含有药物的片 (diltiazem化) 被浸入水中并进行监测.
- 进行了PEO和HPMC片之间的水分行为比较.
主要成果:
- TD-NMR成功估计了非化核的数量,与实验测量一致.
- 与PEO片相比,HPMC矩阵片显示非化核的消失速度较慢.
- HPMC的水化行为受到聚乙烯糖醇 (PEG) 含量的影响.
- TD-NMR数据与化平片的体外药物溶解概况相关性很好.
结论:
- TD-NMR是一种强大而非侵入性的工具,用于评估水友基矩阵片的水化特性.
- 该方法可以区分不同聚合物的水化动态 (HPMC与PEO).
- TD-NMR具有评估凝层特性和预测药物释放性能的潜力.
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