Groёl Sebastian, Menzen Tim, Winter Gerhard
Department of Pharmacy, Ludwig-Maximilians University Munich, 81377 Munich, Germany.
Coriolis Pharma Research GmbH, 82152 Munich, Germany.
Pharmaceutics. 2021 Oct 19;13(10):1735. doi: 10.3390/pharmaceutics13101735.
Studying the thermal history and relaxation of solid amorphous drug product matrices by calorimetry is a well-known approach, particularly in the context of correlating the matrix parameters with the long-term stability of freeze-dried protein drug products. Such calorimetric investigations are even more relevant today, as the application of new process techniques in freeze-drying (which strongly influence the thermal history of the products) has recently gained more interest. To revive the application of calorimetric methods, the widely scattered knowledge on this matter is condensed into a review and completed with new experimental data. The calorimetric methods are applied to recent techniques in lyophilization, such as controlled nucleation and aggressive/collapse drying. Phenomena such as pre- events in differential scanning calorimetry and aging shoulders in isothermal microcalorimetry are critically reviewed and supplemented with data of freeze-dried products that have not been characterized with these methods before.
通过量热法研究固体无定形药物产品基质的热历史和弛豫是一种众所周知的方法，特别是在将基质参数与冻干蛋白质药物产品的长期稳定性相关联的背景下。如今，这种量热研究更为重要，因为冻干中新工艺技术的应用（这对产品的热历史有很大影响）最近受到了更多关注。为了复兴量热法的应用，将关于这一问题的广泛分散的知识浓缩成一篇综述，并补充了新的实验数据。量热法应用于冻干的最新技术，如控制成核和快速/塌陷干燥。对差示扫描量热法中的预事件和等温微量热法中的老化峰等现象进行了批判性综述，并补充了以前未用这些方法表征的冻干产品的数据。
