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Claims for Patent: 6,887,459

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Claims for Patent: 6,887,459

Title: Aerosol composition comprising formoterol
Abstract:The use of a dry powder comprising (A) formoterol, or a pharmaceutically acceptable salt or solvate thereof, or solvate of said salt, and (B) a pharmaceutically acceptable particulate diluent or carrier in an amount of from 400 .mu.g to 5000 .mu.g per .mu.g of (A) for the preparation of an inhalable medicament for the treatment of chronic obstructive pulmonary disease.
Inventor(s): Haeberlin; Barbara (Muenchenstein, CH)
Assignee: Novartis, AG (Basel, CH)
Application Number:10/148,043
Patent Claims: 1. A method of treating chronic obstructive pulmonary disease consisting essentially of administering by inhalation to a subject in need of such treatment an effective amount of a dry powder comprising (A) formoterol, or a pharmaceutically acceptable salt or solvate thereof, or solvate or said salt, and (B) a pharmaceutically acceptable particulate diluent or carrier in an amount of 400 .mu.g to 5,000 .mu.g per .mu.g of (A), wherein said pharmaceutically acceptable diluent or carrier has a median particle diameter of 40 to 100 .mu.m, and said formoterol is the only active ingredient.

2. A method according to claim 1, in which the formoterol (A) is in the form of formoterol fumarate dihydrate.

3. A method of treating chronic obstructive pulmonary disease which comprises administering by inhalation to a subject in need of such treatment an effective amount of a dry powder consisting, or consisting essentially, of (A) formoterol fumarate dihydrate and (B) a pharmaceutically acceptable diluent or carrier in an amount from 400 .mu.g to 5,000 .mu.g per .mu.g of (A), wherein said pharmaceutically acceptable diluent or carrier has a median particle diameter of 40 to 100 .mu.m.

4. A method according to claim 3, in which the diluent or carrier (B) is a saccharide, a sugar alcohol or a mixture thereof.

5. A method according to claim 4, in which the diluent or carrier (B) is lactose.

6. A method according to claim 3, in which the diluent or carrier (B) is present in an amount of 800 to 3000 .mu.g per .mu.g of (A).

7. A method according to claim 3, in which the mean particle diameter of (A) is up to 10 .mu.m.

8. A method according to claim 3, in which the dry powder is in a capsule, the capsule containing a unit dose of (A).

9. A method according to claim 8, in which the capsule contains 12 .mu.g of (A) and 19988-24988 .mu.g of diluent or carrier (B).

10. A method according to claim 3, in which the dry powder is in a reservoir of a multi-dose powder inhaler adapted to deliver a unit dose of (A) per actuation.
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