Details for Patent: 7,479,572
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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), Senanayaka; Chris H. (Shrewsbury, MA), Kessler; Donald W. (Groton, MA) |
Assignee: | Sepracor Inc. (Marlborough, MA) |
Filing Date: | Jan 14, 2008 |
Application Number: | 12/013,848 |
Claims: | 1. A solvent system for conversion of (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C comprising (R,R)-formoterol L-tartrate polymorph B, isopropyl alcohol, water, and at least 13% toluene, wherein the solvent is maintained at from 45.degree. C. to 50.degree. C. 2. A solvent system for conversion of (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C according claim 1, wherein toluene is present in the solvent system at from 13 weight % to 75 weight %. 3. A solvent system for conversion of (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C according to claim 1, wherein the solvent system is a 3.7:1.0:2.0 (w/w/w) isopropyl alcohol:toluene:water mixture. 4. A system for conversion of R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C according to claim 1, wherein the (R,R)-formoterol L-tartrate polymorph B is present at 17 weight % of the system. |