Physical Characterization and Analytical Test of Pharmaceutical Solids II:
Advanced Applications
One-Day Course, E13-17 Monday, November 18, 2013, 830am – 5:00pm
Dr. Steve R. Byrn, Purdue University, West Lafayette, IN
Dr. Xiaoming (Sean) Chen, Shionogi Inc., Florham Park, NJ
COURSE DESCRIPTION
Physical characterization and methods of analysis of pharmaceutical solids are widely applied in drug research and development. Drug substances are generally manufactured as solid-state forms and drug products are typically marketed as solid dosage formulations. Qualitative and quantitative analysis using various solid state methods are necessary for ensuring the quality and stability of drug substances and products. This short course offers some advanced concepts for pharmaceutical analysis including a review of particle size/surface area, hydration/dehydration, and physical stability/physical transformation. It also discusses important applications of analytical methods of pharmaceutical solids in form selection, mixture analysis, solid dispersions, and nanotechnology.
WHO SHOULD ATTEND
This one-day course will benefit formulation scientists, process engineers, analysts, QA and QC managers, regulators, and researchers, who perform process development and manufacture of drug substances, develop formulations of drug products, conduct analytical testing and method development, set up stability programs, and evaluate stability data of drug substances and products.
TOPICS
1. Pharmaceutical Solids-Advanced Concepts
* Particle size/surface area
* Water sorption, hydration/dehydration
* Physical stability/physical transformation
2. Important Applications
* Form selection
* Mixture analysis
* Solid dispersions
* Nanotechnology
ABOUT THE INSTRUCTORS
Dr. Stephen R. Byrn is Charles B. Jordan Professor of Medicinal Chemistry in the School of Pharmacy, Purdue University, West Lafayette, Indiana. He received his B.A. degree in Chemistry from DePauw University and his Ph .D. degree in Chemistry from the University of Illinois, Urbana. He did postdoctoral research at UCLA. His research focuses on solid state chemistry, polymorphism, stability, manufacturing science, quality by design, and medicinal chemistry. Dr. Byrn opened up the field of solid state chemistry of drugs with his research and books of that title (first edition, 1982, second edition, 2000). Dr. Byrn has founded and directed several programs at Purdue University including CAMP, the Center for AIDS Research, the Molecules to Market program, and Purdue’s graduate programs in regulatory and quality compliance. He is also one of the founders and a member of the executive committee of NIPTE (National Institute for Pharmaceutical Technology and Education). He continues to be involved in educating scientists in solid state chemistry, methods of analysis, and regulatory science. Dr. Byrn has served as chair of the Pharmaceutical Sciences Advisory Committee to the FDA and Chair of the Drug Substances Technical Committee, Product Quality Research Initiative. Dr. Byrn has extensive experience as a consultant in the pharmaceutical industry and currently serves as Purdue’s representative to the USP. Dr. Byrn is co-founder of SSCI, Inc. (Solid State Chemical Information) a cGMP research and information Company specializing in polymorphism, crystallization, analysis, problem solving and regulatory issues. SSCI, Inc. is now owned by Aptuit and Dr. Byrn serves as Head of the Aptuit Scientific Advisory Board. Dr. Byrn is also a technical founder of Andara now owned by Cyberkinetics, Inc. Andara specializes in devices and drugs for the treatment of spinal cord injury and CNS diseases.
Dr. Xiaoming (Sean) Chen received his Ph.D. in Industrial and Physical Pharmacy from Purdue University in 2000. He has worked as a project leader in discovery support and preformulation at Schering-Plough Research Institute for five years. He has contributed the nomination of five NCE for development and received one President Award, one Impact Award and three Excellence Awards from Schering-Plough Research Institute. He has also worked in Exploratory Formulation group of Schering-Plough for three years, leading formulation development of two important line extension projects. Dr. Chen has worked in OSI Pharmaceutical for more than three years in the area of formulation and process development for new cancer drugs. Currently, he is a Manager of Pharmaceutical Sciences in Shionogi Inc. Dr. Chen is an expert in physical characterization of solids, crystal form and salt selection, and controlled release formulation. He has published over a dozen of papers in peer-reviewed journals and is a co-inventor of three patents. Dr. Chen is a member of AAPS and has served in PDD award committee for two years.
