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Updated: Jan 25, 2026

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使用风湿学和固态NMR光谱学探测喷雾干燥和融化的无形分散物的可混合性

Sichen Song^1,2, Tianyun Zhang³, Jianchao Xu³

¹Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota 55455, United States.

Molecular pharmaceutics

|January 24, 2026

概括

一种新的风湿学方法有效地估计了混合性,并预测了赛莱科西布 (CEL) 和聚烯立 (PVP) 在无形固体分散 (ASD) 中的结晶. 这种方法有助于设计稳定的ASD配方,以改善药物存储.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
固态化学固态化学

背景情况:

无形固体分散 (ASDs) 提高了药物的溶解性和生物可用性.
在ASD中控制药物结晶对于长期稳定至关重要.
评估ASD的混合性和结晶倾向对于配方开发至关重要.

研究的目的:

评估一种c*指导的高温风湿学方法,用于估计赛莱可西布 (CEL) /聚烯利 (PVP) ASD 的混合性.
通过灭和喷雾干燥制备的ASD的混合性和结晶行为进行比较.
为了验证与固态核磁共振 (ssNMR) 测量对抗的风学方法.

主要方法:

使用灭和喷雾干燥技术制备CEL/PVP ASD.
以临界聚合物度 (c*) 为指导的高温风湿学测量.
固态核磁共振 (ssNMR) 1H T1ρ和1H T1放松时间测量和旋转扩散研究.

主要成果:

在估计ASD混合性时,rheological方法和ssNMR之间发现了一般一致性.
风学方法适用于现有ASD粉末,与可以删除处理历史的ssNMR不同.
当聚合物度超过c* (c > c*) 时,结晶趋势显著降低,从而延迟了药物结晶.
当c < c*时,结晶的开始类似于整洁的无形CEL.

结论:

以c*为指导的风学方法是一种高效的,节约材料的方法,用于评估ASD的混合性和预测结晶稳定性.
这种方法适用于融挤压和喷雾干燥的ASD.
这些发现支持了强大的ASD的合理设计,并提高了长期存储的稳定性.

关键词:

无形固体分散的无形固体分散结晶化结晶化的过程.融灭器可以灭融.混杂性混杂性混杂性度重叠是因为度重叠.物理稳定性物理稳定性类风病学类风病学类风病学固态NMR是一种固态NMR.喷雾干燥喷雾干燥

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