GlobalCompliancePanel to organize RAPS pre-approved webinar on "Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize aRAPS pre-approved webinaron November 15.This course earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion. Jeff Schwegman, Ph.D., founder and chief executive officer of AB BioTechnologies,will be the Speaker at this session.
- Fresno, CA (1888PressRelease) December 18, 2012 - 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.
Areas Covered in the Session:
o Crystalline vs. amorphous vs. mixed systems
o Eutectic melting, glass transition, and collapse temperatures
o Partial collapse vs. meltback
o Examples of failed products
o Principals of thermal analysis
o Thermal analysis equipment and techniques: DSC, DTA, TEA
o Freeze-dry microscopy equipment and techniques
o Applications of thermal analysis and freeze-dry microscopy techniques for solutions and solids
This webinar will impart the following learning objectives:
o Understanding the thermal properties of a formulation (crystalline, amorphous, mixed)
o Understanding the critical temperatures (Tg', Te, Tc) of a formulation
o Understanding different excipients in formulations and how they affect the thermal properties
When:December 18, 10:00 AM PDT | 01:00 PM EDT
By whom:
Jeff Schwegman, Ph. D., develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC at his firm, AB BioTechnologies, of which he is the founder and CEO.
Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University.
Dr. Schwegman holds patents and develops new technologies in lyophilization. He is also the course Director for a 3-day course called Lyophilization Technology, which he teaches through the Center for Professional Innovation and Education. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.
For whom:
The webinar will benefit
o Quality Control Scientists
o Development Scientists
o Production Management professionals
o Quality Assurance Professionals
Duration:90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
###
space
space
Satisfied Users & 
Approved Press Releases
Print
Email
Report Spam