The Food and Drug Administration (FDA) is becoming more educated in the practice and science of lyophilization. As such, they are asking more questions about lyophilization during NDA or ANDA document reviews, site visits to companies producing lyophilized products, etc. It is now expected by the FDA, that companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added to a formulation, why they are using as much as they have added, what are the critical temperatures of the products (glass transition temperature, Tg’ or eutectic melting temperature, Te), etc. Companies that cannot produce this type of information run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin.
The topics described in this session will cover all of the aspects of understanding the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used in formulation and lyophilization cycle development. At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them. By understanding and applying these principles, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the “trial and error” approach to formulation and lyophilization cycle design.
At the conclusion of this 90-minute session, participants will be able to:
- Understand the thermal properties of a formulation (crystalline, amorphous, mixed)
- Understand the critical temperatures (Tg’, Te, Tc) of a formulation
- Understand different excipients in formulations and how they affect the thermal properties
Attendees will learn:
- Crystalline vs. amorphous vs. mixed systems
- Eutectic melting, glass transition, and collapse temperatures
- Partial collapse vs. meltback
- Examples of failed products
- Principals of thermal analysis
- Thermal analysis equipment and techniques: DSC, DTA, TEA
- Freeze-dry microscopy equipment and techniques
- Applications of thermal analysis and freeze-dry microscopy techniques for solutions and solids