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Claims for Patent: 5,795,564

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Claims for Patent: 5,795,564

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 bronchial distribution when administered by inhalation.
Inventor(s): Aberg; Gunnar (Westborough, MA), Morley; John (Richmond-upon-Thames, GB)
Assignee: Sepracor, Inc. (Marlborough, MA)
Application Number:08/613,382
Patent Claims: 1. A method for eliciting a bronchodilator effect while avoiding the concomitant liability of hypersensitivity which comprises administering to a human in need of bronchodilation 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.

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

3. The method according to claim 2 wherein the amount administered by inhalation is about 1 .mu.g to about 100 .mu.g per day.

4. The method according to claim 2 wherein the amount administered orally is about 0.1 to about 1 mg per day.

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

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

7. A method according to claim 3 wherein said amount is administered in divided doses from two to four times a day.

8. A bronchodilator composition in the form of a tablet, capsule, transdermal patch or aerosol, which comprises a pharmaceutically acceptable carrier suitable for a tablet, capsule, transdermal patch or aerosol 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.

9. A composition according to claim 8 adapted for administration by inhalation wherein the amount of (R,R) formoterol is about 6 .mu.g to about 25 .mu.g.

10. A composition according to claim 9 which comprises (R,R) formoterol fumarate dihydrate.

11. A composition according to claim 8 adapted for oral administration.

12. A composition according to claim 11 wherein the amount of formoterol in an oral dosage form is from about 0.1 mg to about 1 mg.

13. A composition according to claim 8 adapted for transdermal administration.

14. A method for eliciting a bronchodilator effect that is more than twice the duration of the bronchodilator effect of a comparable dose of racemic formoterol, which comprises administering to a human in need of bronchodilation an amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, sufficient to alleviate bronchospasms, said (R,R)-formoterol producing a bronchodilator effect that is more than twice the duration of the bronchodilator effect of a comparable dose of racemic formoterol, and said (R,R)-formoterol containing at least 99% by weight of (R,R)-formoterol and less than 1% by weight of (S,S)-formoterol.

15. A method for eliciting a bronchodilator effect that is of longer duration than the bronchodilator effect of a comparable dose of racemic formoterol, which comprises administering to a human in need of bronchodilation an amount of (R,R)-formoterol, or a pharmaceutically acceptable salt thereof, sufficient to alleviate bronchospasms, said (R,R)-formoterol producing a bronchodilator effect that is of longer duration than the bronchodilator effect of a comparable dose of racemic formoterol, and said (R,R)-formoterol containing at least 99% by weight of (R,R)-formoterol and less than 1% by weight of (S,S)-formoterol.
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