Identification of a pharmaceutically acceptable salt of a HMG CoA reductase inhibitor: Development of an API process from bench to plant

ORGN 161

Michael M. Miller, michael.miller@bms.com1, Lindsay Hobson1, Shannon Harper1, Victor Rosso1, Shawn Yin2, Jack Gougoutas2, Otute Akiti1, Subodh Deshmukh1, Chiajen Lai1, Lifen Shen1, Chenkou Wei1, Ray Scaringe2, Ajit Thakur3, Seema Betigeri3, and Rodney L. Parsons Jr.1. (1) Departments of Chemical Process Research and Development & Drug Discovery Chemistry, Bristol-Myers Squibb Co, P.O. Box 5400, Princeton, NJ 08543-5400, (2) Departments of Analytical Research and Development & Material Science, Bristol-Myers Squibb Co, P.O. Box 5400, Princeton, NJ 08543-5400, (3) Departments of Exploratory Biopharmaceutics & Stability, Bristol-Myers Squibb Co, P.O. Box 5400, Princeton, NJ 08543-5400
A scalable process for the multi-kilogram preparation of the API of a development candidate will be presented. The identification and implementation of a suitable salt form will be discussed. Specific highlights of the optimization efforts will be described, including the development of a slurry-to-slurry process and incorporation of an in-line Raman technique to monitor conversion and polymorph transformation on scale.
 

Physical Organic Chemistry, Combinatorial and Process Chemistry, New Reactions and Methodology, Peptides, Proteins and Amino Acids
8:00 PM-10:00 PM, Sunday, April 6, 2008 Morial Convention Center -- Hall A, Poster

Division of Organic Chemistry

The 235th ACS National Meeting, New Orleans, LA, April 6-10, 2008