Pharmaceutical Form Selection New Adventures

Monday, November 8, 2010: 4:35 PM
251 E Room (Salt Palace Convention Center)
Chenkou Wei1, Josh Engstrom1, Chiajen Lai1, Mark Liu1 and Jack Z. Gougoutas2, (1)Process Research and Development, Bristol Myers Squibb, New Brunswick, NJ, (2)Retired Senior Research Fellow, Bristol-Myers Squibb

The selection of the crystalline form for active pharmaceutical ingredients (API) has a significant impact on the performance of the pharmaceutical compound. For form selection, it is critical to identify a form that gives maximum exposure of the compound to the patients and that has the chemical and physical stability required for API processing, API storage and drug product formulation. In many instances standard counterion or polymorph screening, performed in a high throughput or manual format, may not lead to any workable forms. In this presentation, case studies are highlighted for the novel approaches taken to discover several uncommon solvates, salts, and complexes of APIs that have physical properties suitable for manufacturing and a desirable pharmaceutical performance.

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