Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

J. Jeff Schwegman, Ph.D.

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This webinar 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 webinar 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.

Why should you attend :

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.

Areas Covered in the Session: 

  • 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

Learning objectives:

·         Understanding the thermal properties of a formulation (crystalline, amorphous, mixed)

·         Understanding the critical temperatures (Tg’, Te, Tc) of a formulation

·         Understanding different excipients in formulations and how they affect the thermal properties

Who will benefit: 

This webinar will provide valuable assistance to those companies involved in the development and manufacture of lyophilized pharmaceutical, diagnostic, and food products

·         Quality Control Scientists

·         Development Scientists

·         Production Management

·         Quality Assurance

Keywords: cycle design, glass transition, eutectic melting, lyophilized products, thermal analysis

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Speaker: J. Jeff Schwegman, Ph.D.,

J. Jeff Schwegman, Ph.D. iscurrently the founder and chief executive officer of AB BioTechnologies( where he develops formulations, lyophilization cycles,determines residual moisture by Karl Fischer, and provides thermalcharacterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes inspeaking and consulting in parenteral pre-formulation, formulation, analytical,and lyophilization of both small molecules and large biomolecules. He also holds patents and develops newtechnologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in1992 and began working at Cook Imaging in Bloomington Indiana, where he gainedexperience in analytical, formulation and process development. In 1999 he began graduate study in theDepartment of Industrial and Physical Pharmacy at Purdue University under thedirection of Dr. Steve Nail, where his focus of research involved studyingchanges in the physical structure of biological molecules duringlyophilization. Dr. Schwegman receivedhis PhD from Purdue University in 2003, and returned to Bloomington where heworked at Baxter Pharmaceutical Solutions as a Research Scientist in thePharmaceutical Development group. InNovember 2005, he left Baxter and formed BioConvergence LLC with 3 otherfounders which specialized in developing new formulations and manufacturingprocesses for parenteral products. InFebruary 2008, he left BioConvergence, which has become a successful company,to form AB BioTechnologies. He iscurrently the course Director for a 4-day course called “LyophilizationTechnology, a Hands-On Approach”, which he teaches through SP Scientific. He routinely lectures around the world onformulation, stabilization and process development of lyophilized products.