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Claims for Patent: 6,068,833

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Claims for Patent: 6,068,833

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, having a low incidence of the development of tolerance and having increased duration of action.
Inventor(s): Aberg; Gunnar (Westborough, MA), Morley; John (Kew, GB)
Assignee: Sepracor Inc. (Marlborough, MA)
Application Number:09/136,109
Patent Claims: 1. A method of treating asthma, while reducing hypersensitivity, which comprises administering to a human suffering from asthma an amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, sufficient to result in bronchodilation, said (R,R)-formoterol containing at least 99% by weight of (R,R)-formoterol and less than 1% by weight of (S,S)-formoterol.

2. A method of providing relief from bronchospasms, while reducing hypersensitivity, which comprises administering to a human an amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, sufficient to diminish bronchospasms, said (RR)-formoterol containing at least 99% by weight of (R,R)-formoterol and less than 1% by weight of (S,S)-formoterol.

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

4. The method according to claim 3 wherein the amount administered by inhalation is about 1 .mu.g to about 100 .mu.g per day.

5. The method according to claim 3 wherein the amount administered orally is about 0.1 to about 1 mg per day.

6. The method according to claim 2 wherein (R,R) formoterol fumarate dihydrate is administered.

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

8. The method according to claim 7 wherein the amount administered by inhalation is about 1 .mu.g to about 100 .mu.g per day.

9. The method according to claim 7 wherein the amount administered orally is about 0.1 to about 1 mg per day.

10. The method according to claim 1 wherein (R,R) formoterol or pharmaceutically acceptable salt thereof is administered together with a pharmaceutically acceptable carrier.

11. A method according to claim 7 wherein (R,R) formoterol fumarate dehydrate is administered.

12. A method according to claim 8 wherein said amount is administered in divided doses from two to four times a day.

13. A bronchodilator composition in the form of a powder for inhalation which comprises a pharmaceutically acceptable carrier suitable for inhalation and an amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, sufficient to alleviate bronchospasms but insufficient to cause hypersensitivity, said (R,R)-formoterol containing at least 99% by weight of (R,R)-formoterol and less than 1% by weight of (S,S)-formoterol.

14. A composition according to claim 13 adapted for administration by inhalation wherein the amount of (R,R) formoterol is about 6 .mu.g to about 25 .mu.g.

15. A composition according to claim 13 which comprises (R,R) formoterol fumarate dihydrate.
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