LYOPHILIZATION CYCLE COMPARISON AND SCALE-UP OF ESOMEPRAZOLE SODIUM FOR INJECTION BETWEEN LAB SCALE AND SCALE-UP BATCHES VS FDM STUDYAbstract
Lyophilization also known as freeze drying is a process in which water is removed from a product after it was frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption). Esomeprazole sodium for Injection 20 mg and 40 mg formulation was developed by optimized Lyophilization cycle. The objective of the research work was to compare the lyophilsation process cycle between Lab scale and scale up batches. The collapse temperature (Tc) for the product was identified using Freeze-drying microscope (FDM). During manufacturing the samples were exposed to above said collapse temperature to study the impact on product quality. Lab scale manufacturing was executed in Tofflon Lyophilizer 0.5 and scale-up batches were executed in Tofflon Lyophilizer 13. The Lyophilisation cycle and analytical results for both the batches were compared.
Himankar Baishya*, Lin Shao Hui, Xu Xian Ping and Zhang Zibin
R & D, Beijing Sciecure Pharmaceuticals Co., Ltd., Beijing, China
29 May, 2016
07 July, 2016
27 July, 2016
01 November, 2016