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Claims for Patent: 6,866,839

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Claims for Patent: 6,866,839

Title: Methods and compositions for treating pulmonary disorders using optically pure (R,R)-formoterol
Abstract:A method and composition are disclosed utilizing the pure (R,R) isomer of formoterol, which is a potent bronchodilator with reduced adverse effects, a low incidence of the development of tolerance and an increased duration of action, as compared to racemic formoterol.
Inventor(s): Aberg; Gunnar (Westborough, MA), Morley; John (Richmond-upon-Thames, GB)
Assignee: Sepracor Inc. (Marlborough, MA)
Application Number:10/457,123
Patent Claims: 1. A method for treating chronic obstructive pulmonary disease in a human in need of such therapy, the method comprising administering to the human a therapeutically effective amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, the (R,R)-formoterol containing at least 90% by weight of (R,R)-formoterol and less than 10% by weight of (S,S)-formoterol.

2. The method of claim 1, wherein the (R,R)-formoterol is administered by subcutaneous injection, intravenous infusion, inhalation, transdermal delivery or oral administration.

3. The method of claim 2, wherein the (R,R)-formoterol or pharmaceutically acceptable salt thereof is administered together with a pharmaceutically acceptable carrier.

4. The method of claim 2, wherein the (R,R)-formoterol is administered as the fumarate dehydrate salt.

5. The method of claim 2, wherein the (R,R)-formoterol is administered by inhalation and the amount administered is about 1 .mu.g to about 100 .mu.g per day, in single or divided doses.

6. The method of claim 5, wherein the amount administered is about 6 .mu.g to about 25 .mu.g per day, in single or divided doses.

7. The method of claim 6, wherein the amount administered is about 12 .mu.g to about 25 .mu.g per day, in single or divided doses.

8. The method of claim 7, wherein the amount is administered in from two to four divided doses.

9. The method of claim 2, wherein the (R,R)-formoterol is administered by orally and the amount administered is about 0.1 mg to about 1 mg per day.

10. A method for treating chronic obstructive pulmonary disease in a human in need of such therapy, the method comprising administering to the human a therapeutically effective amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, the (R,R)-formoterol containing at least 90% by weight of (R,R)-formoterol and less than 10% by weight of (S,S)-formoterol, and wherein the amount of (R,R)-formoterol is sufficient to treat COPD, but insufficient to cause adverse effects associated with racemic formoterol.

11. The method of claim 10, wherein the (R,R)-formoterol is administered by subcutaneous injection, intravenous infusion, inhalation, transdermal delivery or oral administration.

12. The method of claim 11, wherein the (R,R)-formoterol or pharmaceutically acceptable salt thereof is administered together with a pharmaceutically acceptable carrier.

13. The method of claim 11, wherein the (R,R)-formoterol is administered as the fumarate dehydrate salt.

14. The method of claim 11, wherein the (R,R)-formoterol is administered by inhalation and the amount administered is about 1 .mu.g to about 100 .mu.g per day, in single or divided doses.

15. The method of claim 14, wherein the amount administered is about 6 .mu.g to about 25 .mu.g per day, in single or divided doses.

16. The method of claim 15, wherein the amount administered is about 12 .mu.g to about 25 .mu.g per day, in single or divided doses.

17. The method of claim 16, wherein the amount is administered in from two to four divided doses.

18. The method of claim 11, wherein the (R,R)-formoterol is administered by orally and the amount administered is about 0.1 mg to about 1 mg per day.
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