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Claims for Patent: 8,110,706

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Claims for Patent: 8,110,706

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)
Application Number:12/767,043
Patent Claims: 1. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a highly pure (R,R)-formoterol L-tartrate comprising less than 0.5% by weight of chemical impurities other than formoterol L-tartrate, said chemical impurities including less than 0.1% by weight (based on total crystalline solid) of a compound of formula 8: ##STR00007## wherein said composition is obtained by combining (R,R)-formoterol L-tartrate polymorph A and the pharmaceutically acceptable carrier.

2. An aerosol pharmaceutical composition according to claim 1.

3. An oral pharmaceutical composition according to claim 1.

4. An oral pharmaceutical composition according to claim 3 in the form of a tablet, capsule or syrup.

5. A dry powder pharmaceutical composition for inhalation according to claim 1.

6. The pharmaceutical composition of claim 1, wherein the highly pure (R,R)-formoterol L-tartrate comprises less than about 0.4% by weight of chemical impurities other than formoterol L-tartrate.

7. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a highly pure (R,R)-formoterol L-tartrate comprising less than 0.5% by weight of chemical impurities other than formoterol L-tartrate, said chemical impurities including less than 0.1% by weight (based on total crystalline solid) of a compound of formula 8: ##STR00008## wherein said composition is obtained by combining solid (R,R)-formoterol L-tartrate having a differential scanning calorimetry pattern as shown in FIG. 8 and the pharmaceutically acceptable carrier.

8. An aerosol pharmaceutical composition according to claim 7.

9. An oral pharmaceutical composition according to claim 7.

10. An oral pharmaceutical composition according to claim 9 in the form of a tablet, capsule or syrup.

11. A dry powder pharmaceutical composition for inhalation according to claim 7.

12. The pharmaceutical composition of claim 7, wherein the highly pure (R,R)-formoterol L-tartrate comprises less than about 0.4% by weight of chemical impurities other than formoterol L-tartrate.
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