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水晶乱对奥兰扎固态稳定性的影响

Jayant Iyer¹, Matilde Barbosa², João F Pinto²

¹Research Center Pharmaceutical Engineering GmbH (RCPE), 8010 Graz, Austria.

Journal of pharmaceutical sciences

|November 3, 2024

概括

药物加工过程中的机械应力会造成晶体乱,影响药物的稳定性. 这项研究表明,olanzapine (OLA) 中较高的晶体乱导致储存期间更快的降解,这对药物开发至关重要.

科学领域:

制药科学制药科学
固态化学固态化学
药物的稳定性药物的稳定性

背景情况:

药品的机械加工可以诱导晶体障碍,影响药物的稳定性.
虽然研究了无形化等物理变化,但重结晶与无序药物的降解之间的联系需要更多的关注.
储存期间失调药物的氧化不稳定性是制药开发中的一个关键问题.

研究的目的:

为了研究晶体障碍在加速储存期间对 olanzapine (OLA) 的氧化不稳定性的影响.
探索OLA中的晶体障碍程度和降解动力学之间的关系.
为预测和减轻药物不稳定性在制药产品开发期间提供见解.

主要方法:

低温磨 olanzapine (OLA) 以产生不同程度的晶体障碍.
使用差分扫描热量计 (DSC) 和减弱总反射率里埃转换红外光谱法 (ATR-FTIR) 进行物理状态的表征.
在加速储存条件下使用超高性能液态染色学 (UPLC) 量化降解.

主要成果:

观察到OLA样品的初始结晶度和破坏动力学之间存在正相关性.
在OLA中更高的晶体障碍与加速稳定性储存期间降解率的增加相关.
该研究量化了OLA中的晶体障碍,再结晶和氧化降解之间的相互作用.

结论:

晶体障碍的程度显著影响了olanzapine的氧化降解率.
了解这种关系对于解释分批间的变化和制定预防固体药物不稳定性的策略至关重要.
这些发现有助于通过解决固态稳定性问题来降低制药产品开发的风险.

关键词:

晶体障碍是一种结晶障碍.动态建模动态建模奥兰沙平是什么意思奥兰沙平是什么意思氧化过程中的氧化.再结晶化再结晶化

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