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Details for Patent: 6,299,863

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Details for Patent: 6,299,863

Title: Aerosol formulations containing micronized optically pure (R,R) formoterol for bronchodilating therapy
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)
Filing Date:Mar 27, 2000
Application Number:09/535,200
Claims:1. An inhalable pharmaceutical composition for the treatment of a patient in need of bronchodilating therapy, said composition comprising an amount of micronized formoterol containing at least 90% by weight of (R,R)-formoterol and 10% or less by weight of (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, and a propellant.

2. An inhalable pharmaceutical composition according to claim 1, wherein the amount of micronized formoterol containing at least 90% by weight of (R,R)-formoterol and 10% or less by weight of (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is sufficient to elicit a bronchodilator effect, but insufficient to cause adverse effects associated with racemic formoterol.

3. An inhalable pharmaceutical composition according to claim 1, wherein the amount of micronized formoterol containing at least 90% by weight of (R,R)-formoterol and 10% or less by weight of (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, is about 1 .mu.g to about 100 .mu.g.

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

5. An inhalable pharmaceutical composition according to claim 1, comprising (R,R)-formoterol fumarate dihydrate and a propellant.

6. An inhalable pharmaceutical composition according to claim 1, further comprising a pharmaceutically acceptable carrier.

7. A kit for the treatment of a patient in need of bronchodilating therapy, said kit comprising a metered dose inhaler and an inhalable pharmaceutical composition comprising micronized formoterol containing at least 90% by weight of (R,R)-formoterol and 10% or less by weight of (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, and a propellant.

8. A kit according to claim 7, wherein said micronized formoterol contains at least 99% by weight of (R,R)-formoterol and 1% or less by weight of (S,S)-formoterol.

9. A kit according to claim 8, wherein said micronized formoterol contains greater than 99% by weight of (R,R)-formoterol and less than 1% of (S,S)-formoterol.

10. A kit according to claim 7, wherein the formoterol containing at least 90% by weight of (R,R)-formoterol and 10% or less by weight of (S,S)-formoterol, or a pharmaceutically acceptable salt thereof, comprises formoterol fumarate dihydrate.

11. A kit for the treatment of a patient in need of bronchodilating therapy, said kit comprising (1) an inhalable pharmaceutical composition comprising micronized formoterol containing at least 90% by weight of (R,R)-formoterol and 10% or less by weight of (S,S)-formoterol, or pharmaceutically acceptable salt thereof, and a propellant; and (2) instructions for administering said composition to cause bronchodilation while reducing the concomitant liability of adverse effects.
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