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Details for Patent: 6,919,069

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Details for Patent: 6,919,069

Title: Aerosol formulation containing particulate formoterol, propellant and polar cosolvent
Abstract:A pharmaceutical aerosol formulation comprising (i) particulate medicament, (ii) 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3,-heptafluoro-n-propane or a mixture thereof as propellant, and (iii) 0.01 to 5% w/w based upon the propellant of a polar cosolvent, 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, and which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament.
Inventor(s): Akehurst; Rachel Ann (Hertsfordshire, GB), Taylor; Anthony James (Hertsfordshire, GB), Wyatt; David Andrew (Hertsfordshire, GB)
Assignee: Glaxo Group Limited (Middlesex, GB)
Filing Date:Apr 30, 2003
Application Number:10/425,839
Claims:1. A pharmaceutical aerosol formulation which comprises two or more particulate medicaments, a fluorocarbon or hydrogen-containing fluorocarbon propellant and up to 5% w/w based upon propellant of a polar co-solvent, which formulation is substantially free of surfactant and is free of chlorofluorocarbons.

2. A formulation as claimed in claim 1 wherein said medicaments are selected from the group consisting of an anti-allergic, a bronchodilator and an anti-inflammatory steroid.

3. A formulation as claimed in claim 1 wherein said medicaments are selected from the group consisting of salmeterol, salbutamol, fluticasone propionate, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof.

4. A formulation as claimed in claim 1 which comprises a particulate bronchodilatory medicament and a particulate anti-inflammatory medicament.

5. A formulation as claimed in claim 1 which comprises salmeterol or a physiologically acceptable salt thereof in combination with fluticasone propionate.

6. A formulation as claimed in claim 1 which comprises salmeterol xinafoate in combination with fluticasone propionate.

7. A formulation according to claim 1 wherein the propellant comprises 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoro-n-propane.

8. A formulation according to claim 1 wherein the polar co-solvent is ethanol.

9. A formulation according to claim 1 wherein the medicament is present in an amount of 0.005-5% w/w based on the total weight of the formulation.

10. A formulation according to claim 1 which has a respirable fraction of 20% or more based on the total weight of the formulation.

11. A formulation according to claim 1 wherein said particulate medicament is surface modified.

12. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation which comprises two or more particulate medicaments a fluorocarbon or hydrogen-containing fluorocarbon propellant and up to 5% w/w based upon propellant of a polar co-solvent, which formulation is substantially free of surfactant.

13. A formulation according to claim 1 wherein the polar co-solvent is present in an amount of 0.01 to 5% w/w based upon propellant of a polar co-solvent.

14. A formulation according to claim 1 wherein the polar co-solvent is present in an amount of 0.05 to 3% w/w based upon propellant of a polar co-solvent.

15. A formulation according to claim 1 wherein one of said medicaments is triamcinoline acetonide.

16. A formulation according to claim 1 wherein one of said medicaments is formoterol or a physiologically acceptable salt thereof.

17. A formulation according to claim 13 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

18. A formulation according to claim 14 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

19. A formulation according to claim 15 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

20. A formulation according to claim 16 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

21. A formulation according to claim 4 wherein the anti-inflammatory medicament is a steroidal anti-inflammatory medicament.

22. A method according to claim 12 wherein the respiratory disorder is asthma.

23. A method according to claim 12 wherein the polar co-solvent is present in an amount of 0.01 to 5% w/w based upon propellant of a polar co-solvent.

24. A method according to claim 12 wherein the polar co-solvent is present in an amount of 0.05 to 3% w/w based upon propellant of a polar co-solvent.

25. A method according to claim 12 wherein one of said medicaments is triamcinoline acetonide.

26. A method according to claim 12 wherein one of said medicaments is formoterol or a physiologically acceptable salt thereof.

27. A method according to claim 12 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

28. A method according to claim 23 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

29. A method according to claim 24 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

30. A method according to claim 25 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

31. A method according to claim 26 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof.

32. A pharmaceutical aerosol formulation which comprises (a) a particulate bronchodilatory medicament (b) a particulate steroidal anti-inflammatory medicament (c) a propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof and (d) 0.05-3% w/w based upon propellant of ethanol, which formulation is substantially free of surfactant and is free of chlorofluorocarbons.

33. A pharmaceutical aerosol formulation which consists essentially of (a) a particulate bronchodilatory medicament (b) a particulate steroidal anti-inflammatory medicament (c) a propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof and (d) 0.05-3% w/w based upon propellant of ethanol, which formulation is substantially free of surfactant and is free of chlorofluorocarbons.

34. A formulation according to claim 32 wherein the bronchodilatory medicament is formoterol or a physiologically acceptable salt thereof.

35. A formulation according to claim 33 wherein the bronchodilatory medicament is formoterol or a physiologically acceptable salt thereof.

36. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation according to claim 32.

37. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation according to claim 33.

38. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation according to claim 34.

39. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation according to claim 35.

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

41. A method according to claim 37 wherein the respiratory disorder is asthma.

42. A method according to claim 38 wherein the respiratory disorder is asthma.

43. A method according to claim 39 wherein the respiratory disorder is asthma.
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