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Claims for Patent: 6,589,508

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Claims for Patent: 6,589,508

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 (Richmond-upon-Thames, GB)
Assignee: Sepracor Inc. (Marlborough, MA)
Application Number:09/927,008
Patent Claims: 1. A method of treating asthma in human, the method comprising administering to the human a therapeutically effective amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof.

2. The method according to claim 1, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered orally, transdermally, by inhalation, by subcutaneous injection or by intravenous infusion.

3. The method according to claim 2, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered by inhalation at a dosage of about 1 .mu.g to about 100 .mu.g per day.

4. The method according to claim 3, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered is about 6 .mu.g to about 25 .mu.g per day.

5. The method according to claim 3, wherein the formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, comprises formoterol fumarate dihydrate.

6. The method according to claim 5, wherein the formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, comprises formoterol fumarate dihydrate.

7. A method of treating or preventing bronchospasm in a human, the method comprising administering to the human a therapeutically effective amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof.

8. The method according to claim 7, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered orally, transdermally, by inhalation, by subcutaneous injection or by intravenous infusion.

9. The method according to claim 8, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered by inhalation at a dosage of about 1 .mu.g to about 100 .mu.g per day.

10. The method according to claim 9, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered is about 6 .mu.g to about 25 .mu.g per day.

11. The method according to claim 9, wherein the formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, comprises formoterol fumarate dihydrate.

12. The method according to claim 11, wherein the formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, comprises formoterol fumarate dihydrate.

13. A method of eliciting bronchodilation effect in a human, the method comprising administering to the human a therapeutically effective amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof.

14. The method according to claim 13, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered orally, transdermally, by inhalation, by subcutaneous injection or by intravenous infusion.

15. The method according to claim 14, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered by inhalation at a dosage of about 1 .mu.g to about 100 .mu.g per day.

16. The method according to claim 15, wherein the amount of formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is administered is about 6 .mu.g to about 25 .mu.g per day.

17. The method according to claim 15, wherein the formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, comprises formoterol fumarate dihydrate.

18. The method according to claim 17, wherein the formoterol containing at least 90% by weight (R,R)-formoterol and 10% or less by weight (S,S)-formoterol, comprises formoterol fumarate dihydrate.
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