Fundamentals of Freeze-Drying

Abstract

The development of freeze-dried injectable pharmaceutical products has traditionally been a process of trial and error, both with respect to the composition of the formulation and the process conditions used during freeze-drying. Although this approach ultimately may result in an acceptable product, it is a time-consuming and labor-intensive process, and is unlikely to result in the highest quality product attainable or in a freeze-dry process which is optimized.