Understanding Polymorphism to De-Risk Drug Development
Overview: Determining the polymorphism of a drug—the propensity of a molecule to crystallize in different crystalline arrangements, to form crystalline salts and/or non-salt cocrystals—allows for rational selection of the proper solid form/polymorph for further development.
In this webcast, learn about the basic concepts of the physical phenomenon of crystalline polymorphism in drug molecules and the techniques used to discover and characterize polymorphs.
Explore the effects that different polymorphs may have during drug dissolution and solubilization in the body and resultant bioavailability levels. The benefits of understanding possible polymorphs from a commercial business and risk reduction standpoint will be explored.
In this webinar you will learn:
- Review the definitions of drug solid form, polymorphism, crystallinity, and amorphicity.
- Understand the physical nature of polymorphism and the techniques used to find polymorphs, salts, and cocrystals.
- Develop an appreciation of the importance of profiling polymorphism in drugs for the following factors:
- As a key component of selecting the proper solid form for development
- As a necessary inclusion in key regulatory filings
- As an asset for intellectual property filings, which can prevent competitors from legally formulating your drug using a polymorph not under patent protection.
Who should attend:Scientists, managers, and regulatory professionals involved in small molecule drug development, from early-stage preformulation through late-stage approval.
Steven Johnston, PhD
Director Pharmaceutical Development
Pace® Life Sciences