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在自闭症患者的同时吸水和结晶1:持续两年的稳定性研究

Birte Grönniger¹, Kristof Kimpe², Abhishek Singh²

¹Department of Biochemical and Chemical Engineering, Laboratory of Thermodynamics, TU Dortmund University, Emil-Figge-Str. 70, D-44227 Dortmund, Germany.

Molecular pharmaceutics

|January 4, 2024

概括

无形固体分散 (ASD) 改善药物溶解,但可以随着时间的推移而结晶. 尼菲迪平的ASD结晶速度比赛莱科西布的ASD更快,原因是超和和流动性更高,影响了保质期.

科学领域:

制药科学制药科学
材料科学材料科学材料科学

背景情况:

无形固体分散剂 (ASDs) 增强了难以溶解的活性药物成分 (API) 的溶解.
在ASD中的API通常过和,导致储存期间结晶,这会影响药物产品的稳定性和保质期.

研究的目的:

调查含有尼菲迪平 (NIF) 或塞莱科西布 (CCX) 的喷雾干燥ASD的结晶动力学和保质期.
评估储存条件 (相对湿度,温度) 和聚合物类型对结晶的影响.

主要方法:

用NIF或CCX和聚合物 (聚乙烯 (poly ((vinylpyrrolidone-co-vinyl acetate) 或基基甲基纤维素酸盐糖) 制备喷雾干燥的ASD.
在不同相对湿度条件下储存ASD2年.
使用粉末X射线衍射和显微镜进行定性分析.
使用差异扫描热量计的结晶动力学的定量分析.

主要成果:

在相同的储存条件下,尼菲迪平的ASD表现出明显更快的结晶,而不是塞莱科西布的ASD.
在NIF ASD中,较高的超和和增加的分子流动性有助于它们的加快结晶.
结晶动力学是使用约翰逊-梅尔-阿弗拉米-科尔莫戈罗夫方程来建模的.

结论:

自闭症的结晶率依赖于API,并受到超和分子流动性等因素的影响.
了解结晶动力学对于预测和确保ASD制药的保质期至关重要.

关键词:

在PC-SAFT中使用.无形固体分散的无形固体分散结晶的动力学结晶的动力学不同扫描热量计差异扫描热量计.长期稳定性的长期稳定性相对湿度相对湿度相对湿度

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