Department of Pharmacy, Ludwig Maximilians University, Munich, Germany.
Eur J Pharm Biopharm. 2013 Oct;85(2):214-22. doi: 10.1016/j.ejpb.2013.04.014. Epub 2013 May 2.
In the scientific community as well as in commercial freeze-drying, controlled ice nucleation has received a lot of attention because increasing the ice nucleation temperature can significantly reduce primary drying duration. Furthermore, controlled ice nucleation enables to reduce the randomness of the ice nucleation temperature, which can be a serious scale-up issue during process development. In this review, fundamentals of ice nucleation in the field of freeze-drying are presented. Furthermore, the impact of controlled ice nucleation on product qualities is discussed, and methods to achieve controlled ice nucleation are presented.
在科学界和商业冷冻干燥中，控制冰核的形成受到了广泛关注，因为提高冰核形成温度可以显著缩短初级干燥时间。此外，控制冰核的形成可以减少冰核形成温度的随机性，这在工艺开发过程中可能是一个严重的放大问题。本文综述了冷冻干燥领域的冰核形成的基本原理。此外，还讨论了控制冰核形成对产品质量的影响，并提出了实现控制冰核形成的方法。
