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Serving leading biopharmaceutical companies globally:

Cipla
Deloitte
Fuji
Teva
Cantor Fitzgerald
UBS
Queensland Health
Novartis
Harvard Business School
Citi

Generated: January 21, 2018

DrugPatentWatch Database Preview

Claims for Patent: 8,110,706

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Summary 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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Serving leading biopharmaceutical companies globally:

Cipla
Teva
Argus Health
Medtronic
Chinese Patent Office
Merck
Mallinckrodt
Express Scripts
AstraZeneca

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