Thermal Characterization / Optimized Formulations and Lyophilization Cycles

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SP Scientific

To view the full webinar, please visit: http://www.spscientific.com/Empirical... This presentation will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity). Understanding if a crystalline, amorphous, mixed, and or metastable system is present in our products, is critical in developing a sound, stable formulation that can easily be freeze-dried. Choosing excipients based solely on their stability imparting characteristics, without taking into account their thermal properties, can result in disastrous results both in the physical structure of the solids and on the long term stability. Next, there will be a thorough discussion of the analytical techniques used to characterize the thermal properties of the formulated product. These techniques allow the development scientist to understand not only what types of materials are present, but also the critical temperatures that are associated with these materials (glass transition temperature, eutectic melting temperature, annealing temperature, etc.). Finally, the presentation will conclude with a brief discussion of some of the specialized analytical techniques that can be employed to characterize the lyophilized solids. Understanding the physical properties of the dried solids allows the development scientist to be able to troubleshoot, diagnose, and correct a problematic formulation and or lyophilization cycle.