Details for Patent: 7,964,753
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| Title: | Formoterol tartrate process and polymorph |
| Abstract: | A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph. |
| Inventor(s): | Tanoury; Gerald J. (Hudson, MA), Senanayake; Chris H. (Brookfield, CT), Kessler; Donald W. (Groton, MA) |
| Assignee: | Sunovion Pharmaceuticals Inc. (Marlborough, MA) |
| Filing Date: | Jun 07, 2010 |
| Application Number: | 12/794,991 |
| Claims: | 1. A process for preparing (R,R)-formoterol L-tartrate polymorph A comprising: converting (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C in a solvent system comprising isopropyl alcohol, water, and at least 13% toluene, wherein the solvent system is maintained at between 40.degree. C. and 55.degree. C., and preparing (R,R)-formoterol L-tartrate polymorph A from (R,R)-formoterol L-tartrate polymorph C through crystallization. 2. A process according to claim 1, wherein the solvent system is maintained at between 40.degree. C. and 45.degree. C. 3. A process according to claim 1, wherein the solvent system is maintained at between 45.degree. C. and 50.degree. C. |
