Research Triangle Park, NC, April 30, 2010 – Alan D. Hendricker, Ph.D., principal scientist for Catalent Pharma Solutions, will be leading a discussion titled, “Migration Study Design and Case Study of Benzophenone Leaching from Packaging Componentry into Drug Product Solution” during PharmaED’s “Extractables and Leachables 2010” conference being held in San Francisco, California on May 3 through 4, 2010.

Dr. Hendricker’s talk will focus on a case study to source, quantitate and eliminate a contaminant migrating from the drug product container closure system into a nasal spray formulation during stability storage.  The results of this study will be presented.  Additionally, this talk will focus on migration study design.  Migration studies can be used to anticipate potential problems with leachables and provide relatively rapid answers concerning materials compatibility issues.  Linking migration studies to materials characterization studies will also be discussed in terms of understanding which species to focus on and applying appropriate analytical methodology.

Dr. Hendricker received his B.S. in Chemistry from Ohio University in Athens, Ohio, USA, and his Ph.D. in Chemistry from the Colorado School of Mines in Golden, Colorado, USA. He specializes in gas chromatography mass spectrometry (GC-MS), liquid chromatography mass spectrometry (LC-MS), and headspace analysis for volatile impurities.  Dr. Hendricker was a member of the PQRI working group that developed the Safety Threshold and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products in 2006. 

For more information on Catalent’s broad range of biopharmaceutical development services, go to www.catalent.com/development.   For more information on the conference please visit www.pharmaedresources.com.

About Catalent

Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries.  Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes.  Catalent employs approximately 9,100 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com.