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Claims for Patent: 7,067,502

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Claims for Patent: 7,067,502

Title:Combinations of formoterol and mometasone furoate for asthma
Abstract:A medicament containing, separately or together, (A) formoterol or a pharmaceutically acceptable salt thereof or a solvate of formoterol or a solvate of the salt and (B) mometasone furoate, for simultaneous, sequential or separate administration in the treatment of an inflammatory or obstructive airways disease.
Inventor(s): Hassan; Ian Francis (Morris Plains, NJ), Clarke; Jeremy Guy (Bath, GB), Danahay; Henry Luke (Horsham, GB)
Assignee: Novartis AG (Basel, CH)
Application Number:10/718,316
Patent Claims: 1. A medicament containing, separately or together, (A) formoterol or a pharmaceutically acceptable salt thereof or a solvate of formoterol or a solvate of said salt and (B) mometasone furoate, for simultaneous, sequential or separate administration in the treatment of an inflammatory or obstructive airways disease, wherein said (A) or (B), or (A) and (B) are in inhalable form in an atomizable composition or in a dry powder, said medicament has a weight ratio of (A) to (B) from 1:2 to 1:100.

2. A medicament according to claim 1 which is a pharmaceutical composition comprising a mixture of effective amounts of (A) and (B), optionally together with a pharmaceutically acceptable carrier, said medicament has a weight ratio of (A) to (B) from 1:2 to 1:100.

3. A medicament according to claim 1, in which (A) is formoterol fumarate dihydrate.

4. A medicament according to claim 2, in which (A) is formoterol fumarate dihydrate.

5. A medicament according to claim 1, which is an inhalable aerosol comprising a mixture of (A) and (B) in solution or dispersion in a propellant, or a combination of an aerosol containing (A) in solution or dispersion in a propellant with an aerosol containing (B) in solution or dispersion in a propellant.

6. A medicament according to claim 5, in which (A) or (B), or (A) and (B), are in dispersion in the propellant, which is a halogen-substituted hydrocarbon.

7. A medicament according to claim 6, in which (A) or (B), or each of (A) and (B), has an average particle diameter of up to 10 .mu.m.

8. A medicament according to claim 1, which is an inhalable nebulizable composition comprising a dispersion of (A) and (B) in an aqueous, organic or aqueous/organic medium or a combination of a dispersion of (A) in said medium with a dispersion of (B) in said medium.

9. A medicament according to claim 1, which is an inhalable dry powder comprising finely divided (A) or (B), or finely divided (A) and (B), optionally together with a pharmaceutically acceptable carrier in finely divided form.

10. A medicament according to claim 9, in which the carrier is present and is a saccharide.

11. A medicament according to claim 10, in which the carrier is lactose.

12. A medicament according to claim 9, in which (A) or (B), or each of (A) and (B), has an average particle diameter up to 10 .mu.m.

13. A medicament according to claim 1, in which said ratio is from 1:10 to 1:25.

14. A medicament according to claim 2, in which the weight ratio of (A) to (B) is from 1:10 to 1:25.

15. A medicament according to claim 2, which is a dry powder in a capsule, the capsule containing from 3 to 36 .mu.g of (A) as formoterol fumarate dihydrate, from 25 .mu.g to 800 .mu.g of (B) and a pharmaceutically acceptable carrier in an amount to bring the total weight of dry powder per capsule to between 5 mg and 50 mg.

16. A medicament according to claim 2, which is a dry powder comprising, by weight, from 3 to 36 parts of (A) as formoterol fumarate dihydrate, from 25 to 800 parts of (B) and 2164 to 24972 parts of a pharmaceutically acceptable carrier.

17. A method of treating an inflammatory or obstructive airways disease which comprises administering to a subject in need of such treatment effective amounts of (A) as defined in claim 1 and (B) as defined in claim 1.

18. A method of treating an inflammatory or obstructive airways disease which comprises administering to a subject in need of such treatment an effective amount of a medicament according to claim 2.

19. A pharmaceutical kit comprising (A) as defined in claim 1 and (B) as defined in claim 1 in separate unit dosage forms, said forms being suitable for administration of (A) and (B) in effective amounts, together with one or more inhalation devices for administration of (A) and (B), wherein the weight ratio of (A) to (B) is from 1:2 to 1:100.

20. A medicament according to claim 1, wherein said medicament has a weight ratio of (A) to (B) from 1:5 to 1:50.

21. A medicament according to claim to claim 2, wherein said medicament has a weight ratio of (A) to (B) from 1:5 to 1:50.
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