Piramal Pharma Solutions Press Releases

Press Releases

Difficult-to-Lyophilize Products: A Brief Look at Lyophilization Development

Posted on Tue, Dec 18, 2012 @ 12:31 PM by Charles Reichel in lyophilization, in lyophilized products, in product development, in lyocycle optimization

In order to effectively develop a lyophilization cycle, it is important to understand the glass transition temperature (through Differential Scanning Calorimetry “DSC”) and collapse temperature (through Freeze-Drying Microscopy “FDM”) of the formulation between the liquid, glassy, and frozen states.  These values will help define the maximum product temperature that the product can achieve during primary drying in order to prevent collapse or melt back of the product due to incomplete sublimation of unbound moisture and/or solvent.  This should happen prior to the ramp to secondary drying with final removal of the bound moisture and/or solvent. 

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