Abstract

REVIEW ON LYOPHILIZATION TECHNIQUE

Tushar R. Jadhav* and R. S. Moon

ABSTRACT

While arriving a new century, lyophilization in the pharmaceutical field has been subjected to ongoing development and steady expansion. This review objectives to highlight recent advances but also to discuss further challenges in lyophilization. At first, the three major steps of a typical lyophilization process, namely freezing, primary drying, and secondary drying, are described in brief. Additionally, a general description of the essential components and their function in a lyophilizer is given. The principle of lyophilization; heat transfer and mass transfer also described. With respect to recent advances in lyophilization, the expanded range of pharmaceutical applications based on lyophilization is brief. Moreover, novel formulation aspects and novel container systems are discussed and the importance of the freezing step is outlined. Furthermore, the dogma of ―never lyophilizing above the glass transition temperature‖ is argued and recent insights into novel stabilization concepts are provided. Process analytical technology (PAT) and quality by design (QbD) are now leading issues and the design of the lyophilization equipment might have to be reconsidered in the future. Nowadays, lyophilization has also gained importance for the preservation and stabilization of biological products, hormones, proteins, nucleic acid based pharmaceuticals.

Keywords: Lyophilization, Recent trend, novel formulation, novel container.