Abstract

DEVELOPMENT AND OPTIMIZATION OF LYOPHILIZATION CYCLE

Sandeep kumar, Namrata Gautam, Dr. Md. Akram Minhaj*, Sana, Sapna Kapoor

Abstract

Development and optimization of Lyophilization cycle or freeze drying cycle is a trial and Error method which is not well known and understood properly. This technology is developed for individual pharmaceutical products for preservation and to improve the stability of product during its storage condition. This technique is applicable for thermo labile substances. Development and optimization of lyophilization cycle require scientific knowledge and experience in this field. Development and optimization of Lyophilization cycle for most of the products depends upon some justified simple rules based on well accepted scientific principles. The aims and objectives of this review article are to study all the critical parameters and to develop knowledge on which Lyophilization cycle depends. In the present review article, importance of controlled freezing, control of ice nucleation, Glass transition temperature, Eutectic temperature, Significance of collapse temperature during primary drying, and impact of freezing on primary drying and rest of the lyophilization cycle is elaborated.

Keywords: Lyophilization, Eutectic temperature, Collapse temperature, Primary drying.