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Lyophilization Technique:A Review


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1 Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik, India
     

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While arriving 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. 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. The expanded range of pharmaceutical applications based on lyophilization is brief. Now a days, lyophilization has also gained importance for the preservation and stabilization of biological products, hormones, proteins, nucleic acid based. This review deals with the solubliser, stabilizer and cryoprotectant used in various lyophilized formulations of the molecules. The role of solubliser, stabilizer and cryoprotectant has been discussed.

Keywords

Lyophilization, Importance of Lyophilization Process, Methods of Lyophilization Process, Excipients Used in Lyophilized Formulation.
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  • Lyophilization Technique:A Review

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Authors

Pradnya M. Khandagale
Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik, India
Bhushan Bhairav
Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik, India
R. B. Saudagar
Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik, India

Abstract


While arriving 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. 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. The expanded range of pharmaceutical applications based on lyophilization is brief. Now a days, lyophilization has also gained importance for the preservation and stabilization of biological products, hormones, proteins, nucleic acid based. This review deals with the solubliser, stabilizer and cryoprotectant used in various lyophilized formulations of the molecules. The role of solubliser, stabilizer and cryoprotectant has been discussed.

Keywords


Lyophilization, Importance of Lyophilization Process, Methods of Lyophilization Process, Excipients Used in Lyophilized Formulation.