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Claims for Patent: 5,658,549

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Claims for Patent: 5,658,549

Title: Aerosol formulations containing propellant 134a and fluticasone propionate
Abstract:This invention relates to aerosol formulations of use for the administration of medicaments by inhalation, in particular a pharmaceutical aerosol formulation which comprises particulate medicament selected from the group comprising salmeterol, salbutamol, fluticasone propionate and physiologically acceptable salts and solvates thereof and a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant, which formulation is substantially free of surfactant. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as defined is also described.
Inventor(s): Akehurst; Rachel Ann (Ware, GB3), Taylor; Anthony James (Ware, GB3), Wyatt; David Andrew (Ware, GB3)
Assignee: Glaxo Group Limited (London, GB2)
Application Number:08/444,925
Patent Claims: 1. A pharmaceutical aerosol formulation consisting essentially of particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof, and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, the particulate medicament being present in an amount from 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

2. A formulation as claimed in claim 1 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

3. A formulation as claimed in claim 1 which has a respirable fraction of 20% or more by weight of the particulate medicament.

4. A pharmaceutical aerosol formulation consisting essentially of particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof, and 1,1,1,2-tetrafluoroethane as propellant, which formulation is free of surfactant, the particulate medicament being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

5. A pharmaceutical aerosol formulation consisting of particulate medicament consisting of fluticasone propionate or a physiologically acceptable solvate thereof, and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicament being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

6. A formulation as claimed in claim 4 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

7. A formulation as claimed in claim 5 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

8. A formulation as claimed in claim 4 which has a respirable fraction of 20% or more by weight of the particulate medicament.

9. A formulation as claimed in claim 5 which has a respirable fraction of 20% or more by weight of the particulate medicament.

10. A pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof; a particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof; and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicaments being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns which formulation is free of surfactant.

11. A pharmaceutical aerosol formulation consisting of particulate medicament consisting of fluticasone propionate or a physiologically acceptable solvate thereof; particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof; and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicaments being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

12. A formulation as claimed in claim 10 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

13. A formulation as claimed in claim 11 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

14. A formulation as claimed in claim 10 which has a respirable fraction of 20% or more by weight of the particulate medicaments.

15. A formulation as claimed in claim 11 which has a respirable fraction of 20% or more by weight of the particulate medicaments.

16. A formulation as claimed in claim 10 which contains fluticasone propionate or a physiologically acceptable solvate thereof and salmeterol or salbutamol or a physiologically acceptable salt thereof.

17. A formulation as claimed in claim 11 which contains fluticasone propionate or a physiologically acceptable solvate thereof and salmeterol or salbutamol or a physiologically acceptable salt thereof.

18. A formulation as claimed in claim 10 which contains fluticasone propionate and salmeterol xinafoate.

19. A formulation as claimed in claim 11 which contains fluticasone propionate and salmeterol xinafoate.

20. A pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof; a particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate, mixtures thereof and physiologically acceptable salts and solvates thereof; and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicaments, the particulate medicaments being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

21. A formulation as claimed in claim 20 which contains fluticasone propionate and salmeterol xinafoate.

22. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting essentially of particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof, and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based on the weight of medicament, the particulate medicament being present in an amount from 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

23. A method as claimed in claim 22 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

24. A method as claimed in claim 22 which has a respirable fraction of 20% or more by weight of the particulate medicament.

25. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting of particulate medicament consisting of fluticasone propionate or a physiologically acceptable solvate thereof, and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicament being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

26. A method as claimed in claim 25 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

27. A method as claimed in claim 25 which has a respirable fraction of 20% or more by weight of the particulate medicament.

28. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting essentially of particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof; a particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof; and 1,1,1,2-tetrafluoroethane as propellant which formulation contains less than 0.0001% w/w surfactant based on the weight of medicament the particulate medicaments being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

29. A method as claimed in claim 28 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

30. A method as claimed in claim 28 which contains fluticasone propionate and salmeterol xinafoate.

31. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting of particulate medicament consisting of fluticasone propionate or a physiologically acceptable solvate thereof; a particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof; and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicaments being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

32. A method as claimed in claim 31 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.

33. A method as claimed in claim 32 which contains fluticasone propionate and salmeterol xinafoate.

34. A formulation as claimed in claim 20 wherein the particulate medicaments are present in an amount of 0.01% to 1% w/w relative to the total weight of the formulation.

35. A formulation as claimed in claim 20 which has a respirable fraction of 20% or more by weight of the particulate medicaments.

36. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof; and 1,1,1,2-tetrafluoroethane as propellant, which formulation is free of surfactant, the particulate medicament being present in an amount from 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

37. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is fluticasone propionate or physiologically acceptable solvate thereof; particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts or solvates thereof; and 1,1,1,2-tetrafluoroethane as propellant, which formulation is free of surfactant, the particulate medicaments being present in an amount of 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

38. A method as claimed in claim 37 wherein the particulate medicaments are fluticasone propionate and salmeterol xinafoate.

39. A method as claimed in claim 38 wherein the particulate medicaments are present in an amount of from 0.01 to 1% w/w relative to the total weight of the formulation.
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