This preliminary program is subject to change.

Multi-Layer Units Manufactured by Compression


Description:
Manufacture of multi-layer tablets by compression is a common occurrence in the pharmaceutical industry that has a number of challenges. The major concern centers on unit integrity, and the root causes of unit failure. Failure can occur at the interface or in either layer. Theoretically, failure can be mitigated by material selection for each layer and process parameter optimization. The purpose of the session is to explore techniques for characterizing multi-layer units, predicting failure, addressing material property and manufacturing requirements to maximize unit integrity. The desired outcome is to expand the understanding of multi-unit integrity.

Sponsor:
Product Design


Chair:
Omar L. Sprockel
Senior Principal Scientist
Bristol-Myers Squibb
Drug Product Process & Package Development
One Squibb Drive
New Brunswick, NJ 08903
Phone Number: 732-227-6448
Email: Omar.Sprockel@BMS.com

Co-Chair:
John Gawel
Sr Research Scientist II
Bristol-Myers Squibb
Biopharmaceutics R & D
One Squibb Drive
New Brunswick, NJ 08903
Phone Number: 000-000-0000
Email: john.gawel@bms.com


Papers:
Challenges in Developing A Bilayer Tablet
Admassu Abebe, Bristol-Myers Squibb Company; Ilgaz Akseli, Rutgers University; Kyle Martin, Bristol-Myers Squibb Company; Omar Sprockel, Bristol-Myers Squibb Company; Alberto Cuitino, Rutgers University
Fundamental Concepts and Practical Experimentation on Multi-Layer Tablets
Adam Procopio, Merck & Co., Inc.; Katherine Chin, Merck & Co., Inc.; Larrry Rosen, Merck & Co., Inc.; Antonios Zavaliangos, Drexel University
On the Structural Integrity of Bilayer Tablets Upon Ejection
Antonios Zavaliangos, Drexel University; Gerald Klinzing, Drexel University; Adam Procopio, Merck & Co., Inc.
Mechanistic Characterization of Bilayer Tablets .I: The Role of Pre-Compaction and Compaction Forces
Ilgaz Akseli, Rutgers University; Admassu Abebe, Bristol-Myers Squibb Company; Omar Sprockel, Bristol-Myers Squibb Company; Alberto Cuitino, Rutgers University
Mechanistic Characterization of Bilayer Tablets. II: The Effect of Layer Sequence and Fracture Surface Topography
Ilgaz Akseli, Rutgers University; Admassu Abebe, Bristol-Myers Squibb Company; Omar Sprockel, Bristol-Myers Squibb Company; Alberto Cuitino, Rutgers University
See more of this Group/Topical: Process Development Division