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通过使用正电子消灭寿命光谱测量,对冷化配方的稳定性进行评估

Luca Chiari¹, Yuta Shiga¹, Naoto Sakurai¹

¹Department of Applied Chemistry and Biotechnology, Chiba University, 1-33, Yayoi, Inage, Chiba 263-8522 Japan.

Journal of pharmaceutical sciences

|August 23, 2025

概括

在冷凍配方中含有較高的糖類含量可透過自由體積測量而降低分子流動性,提高藥物穩定性. 聚子灭绝寿命光谱可以评估这种稳定性.

科学领域:

制药科学
材料科学
物理化学

背景情况:

溶解成份对于药物的稳定性至关重要.
了解分子运动是预测配方稳定性的关键.
聚子灭绝寿命光谱 (PALS) 提供了对自由体积和分子动态的见解.

研究的目的:

评估含有基乙基粉,糖类和多的冷解配方的药物稳定性.
研究自由体积,分子流动性和配方稳定性之间的关系.
评估PALS用于预测复杂的冷解系统的稳定性.

主要方法:

使用正电子消灭寿命光谱 (PALS) 系统测量自由体积.
与自由体积相对应的正正体取消灭寿命的分析.
与差分扫描热量计 (DSC) 和固态质子核磁共振 (ss-NMR) 的稳定性指数的PALS衍生的自由体积比较.

主要成果:

随着糖/粉混合率的增加,观察到自由体积和分子流动性的减少.
含糖量较高的配方表现出更高的药物稳定性.
不同类型的糖化合物的配方之间没有发现自由体积的显著差异.
在自由体积和放松时间 (ss-NMR) 之间发现了正相关性,但与玻璃过渡温度 (DSC) 没有相关性.

结论:

解凍成份中的糖類含量增加與自由體積減少和穩定性改善有關.
PALS是一种有价值的技术,用于评估分子流动性,并预测冷解配方的药物稳定性.
自由体积测量可以作为复杂药物输送系统稳定的可靠指标.

关键词:

放热化移动性稳定性

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