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Details for Patent: 6,893,628

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Details for Patent: 6,893,628

Title: Aerosol formulations containing P134a and particulate medicament
Abstract:A pharmaceutical formulation comprising (i) one or more particulate medicaments, and (ii) 1,1,1,2-tetrafuoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, particulate medicament being present in an amount from 00005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns, with the proviso that the medicament is other than salmeterol, salbutamol, fluticasone propionate, beclomethasone dipropionate or a physiologically acceptable salt or solvate thereof and with the proviso that when the formulation consists of betamethasone, ergotamine tartrate or sodium cromoglycate and 1,1,1,2-tetrafluoroethane the weight to weight ratio of medicament to propellant is other than 69:7900 or 0.866% w/w.
Inventor(s): Akehurst; Rachel Ann (Ware, GB), Taylor; Anthony James (Ware, GB), Wyatt; David Andrew (Ware, GB)
Assignee: Glaxo Group Limited (Middlesex, GB)
Filing Date:Mar 31, 2003
Application Number:10/401,722
Claims:1. A pharmaceutical aerosol formulation comprising a particulate medicament which is budesonide and 1,1,1,2-tetrafluoroethane as propellant, which formulation is substantially free of surfactant, is substantially free of chlorofluorocarbons and is free of alcohols and wherein the medicament is present in an amount of 0.01-1% w/w relative to the total weight of the formulation.

2. A formulation as claimed in claim 1 wherein said formulation contains two or more particulate medicaments.

3. A formulation as claimed in claim 2 which comprises a particulate bronchodilatory medicament and a particulate anti-inflammatory steroid medicament.

4. A pharmaceutical aerosol formulation consisting essentially of particulate medicament which is budesonide optionally in combination with a particulate anti-inflammatory steroid medicament and 1,1,1,2-tetrafluoroethane as propellant which formulation is substantially free of surfactant and wherein the medicament is present in an amount of 0.01-1% w/w relative to the total weight of the formulation.

5. A pharmaceutical aerosol formulation consisting of particulate medicament which is budesonide optionally in combination with other medicaments and 1,1,1,2-tetrafluoroethane as propellant wherein the medicament is present in an amount of 0.01-1% w/w relative to the total weight of the formulation.

6. A pharmaceutical aerosol formulation as claimed in claim 4 consisting essentially of particulate medicament which is budesonide and 1,1,1,2-tetrafluoroethane as propellant wherein the medicaments present in an amount of 0.01-1% w/w relative to the total weight of the formulation.

7. A formulation as claimed in claim 4 wherein said formulation contains two or more particulate medicaments.

8. A formulation as claimed in claim 5 wherein said formulation contains two or more particulate medicaments.

9. A formulation as claimed in claim 7 which comprises a particulate bronchodilatory medicament and a particulate anti-inflammatory steroid medicament.

10. A formulation as claimed in claim 8 which comprises a particulate bronchodilatory medicament and a particulate anti-inflammatory steroid medicament.

11. A formulation as claimed in claim 2 which comprises particulate budesonide in combination with particulate formoterol or a physiologically acceptable salt thereof.

12. A formulation as claimed in claim 7 which comprises particulate budesonidein combination with particulate formoterol or a physiologically acceptable salt thereof.

13. A formulation as claimed in claim 8 which comprises particulate budesonide in combination with particulate formoterol or a physiologically acceptable salt thereof.

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

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

16. A formulation as claimed in claim 7 which has a respirable fraction of 20% or more by weight of the medicament.

17. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 1.

18. A method according to claim 17 wherein the respiratory disorder is asthma.

19. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 3.

20. A method according to claim 19 wherein the respiratory disorder is asthma.

21. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 4.

22. A method according to claim 21 wherein the respiratory disorder is asthma.

23. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 5.

24. A method according to claim 23 wherein the respiratory disorder is asthma.

25. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 6.

26. A method according to claim 25 wherein the respiratory disorder is asthma.

27. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 13.

28. A method according to claim 25 wherein the respiratory disorder is asthma.

29. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 9.

30. A method according to claim 29 wherein the respiratory disorder is asthma.

31. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 10.

32. A method according to claim 31 wherein the respiratory disorder is asthma.

33. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 11.

34. A method according to claim 33 wherein the respiratory disorder is asthma.

35. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 12.

36. A method according to claim 35 wherein the respiratory disorder is asthma.

37. A formulation as claimed in claim 1 which is free of ethanol.

38. A method of treatment of asthma which comprises administration by inhalation of an effective amount of a formulation according to claim 37.

39. A formulation as claimed in claim 3 which is free of ethanol.

40. A method of treatment of asthma which comprises administration by inhalation of an effective amount of a formulation according to claim 39.

41. A formulation as claimed in claim 11 which is free of ethanol.

42. A method of treatment of respiratory disorders which comprises administration by inhalation of an effective amount of a formulation according to claim 41.

43. A method according to claim 42 wherein the respiratory disorder is asthma.
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