Investigation of an Unexpected Dehydration Behavior and its Impact on Material Properties

Roxana Schlam, Materials Science & Engineering, Drug Product Science & Technology, Bristol-Myers Squibb, New Brunswick, New Jersey, U.S.A. (roxana.schlam@bms.com)

The selected form of a drug is a monohydrate and was found to display unusual dehydration behavior.  A detailed elucidation using thermal analysis and other solid-state characterization techniques are presented to discuss the discovery, elucidation, and understanding of this phenomenon in the bulk properties, and its impact on API processing and drug product performance.  The knowledge gathered from this work has implications beyond this project and may be relevant to other hydrated pharmaceutical solids.

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Abstract Reference & Short Personal Biography of Presenting Author

Dr. Roxana F. Schlam received her B.Sc. in Chemistry from Hebrew University in Jerusalem, Israel and graduated with a Ph.D. in Chemistry from Brandeis University in Waltham, Massachusetts in the United States where she focused on structure/reactivity relationships in the solid state under Professor Bruce Foxman.  She also did a postdoc at Purdue University in Indiana with Professors Stephen Byrn and Kenneth Morris where she applied her crystallography knowledge and learned about solid-state properties of active pharmaceutical ingredients and the pharmaceutical industry. Dr. Schlam started her career in the industry in the Solid-State Science group at Searle which became Pharmacia and then Pfizer.After five years, Dr. Schlam moved to New Jersey to work in the Materials Science and Engineering group at Bristol-Myers Squibb where she has been for almost 16 years.  Dr. Schlam’s research interests include the study of thermodynamics in solid-state systems and understanding bulk properties at the molecular level. Dr. Schlam holds numerous patents, scientific publications and presentations in the solid-state field of pharmaceuticals and also has extensive experience on intellectual property of crystalline forms.  Dr. Schlam is also an Adjunct Full Professor at Long Island University College of Pharmacy and Health Sciences where she lectures at the graduate level an Introduction to Solids and also Polymorphism and Hydrates: Systems, Stability and Analysis.