Freeze‐Drying, Pharmaceuticals

Abstract This article provides an overview of the fundamental aspects for pharmaceutical freeze‐drying, including the rationale for freeze‐drying process design and control, the basics of formulation development for freeze‐drying, the importance of the container‐closure system, and a general description of pharmaceutical freeze‐dryers. In the second part of this article, the challenges in freeze‐drying scale‐up and transfer, freezing control, use of cosolvent, freeze‐drying in syringes, process analytical technology, and quality‐by‐design in freeze‐drying have been discussed, and some new advancements related to these aspects are also highlighted.