Lyophilization of pharmaceutical products: From concept to reality

Krisanin Chansanroj,Peeracha Thanawattanawanich

Pharma Nueva Co.,Ltd.,171/1-2 Soi Chokechairuammitr,Vibhavadi Rangsit Road,Bangkok 10900,Thailand

Lyophilization of pharmaceutical products: From concept to reality

Krisanin Chansanroj*,Peeracha Thanawattanawanich

Pharma Nueva Co.,Ltd.,171/1-2 Soi Chokechairuammitr,Vibhavadi Rangsit Road,Bangkok 10900,Thailand

A R T I C L E I N F O

Article history:

Available online 23 November 2015

Lyophilization

Pharmaceutical products

Freeze-drying or lyophilization is a multi-stage operation of effectively drying a material while preserving its biological properties.The material is subject to being frozen and sublimated under vacuum upon heating.Lyophillized products are more stable,easily transported and quickly reconstituted.A beneft of low-temperature operation envisages its applications in pharmaceuticals for heat-sensitive components including vaccine and biological products.To date,analyses of the freeze-drying process have been changed from physical aspects of freezing and sublimation to a more sophisticated examination of the effects of the process on the chemical structures and the biological properties of the products themselves [1].In this study,development of some lyophilized products was demonstrated with a focus on process optimization to minimize a cycle time and increase productivity in commercial production.Thermal behaviors of the product were examined by Differential Scanning Calorimetry under freezing and heating conditions to design appropriate freeze-drying cycles.Experimentation was performed with a laboratory lyophilizer to verify critical process parameters including freezing rate,drying temperature,drying time and pressure manipulation.Finally,a success of process transfer from the laboratory bench to more diversifed industrial operations was an accomplishment of basic knowledge and understanding of the equipment operation,environmental concerns and sterile handling of the bulk product.

R E F E R E N C E

[1]Rey L,May JC.Freeze-drying/lyophilization of pharmaceutical and biological products.2nd ed.New York:Marcel Dekker.; 2004.

*E-mail address:krisanin.chansanroj@pharmanueva.com.

Peer review under responsibility of Shenyang Pharmaceutical University.

http://dx.doi.org/10.1016/j.ajps.2015.10.025

1818-0876/?2016 The Authors.Production and hosting by Elsevier B.V.on behalf of Shenyang Pharmaceutical University.This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).