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Details for Patent: 5,817,293

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Details for Patent: 5,817,293

Title: Canister containing aerosol formulations containing P134a and particulate medicaments
Abstract:This invention relates to a canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy including a propellant which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve and contains a pharmaceutical aerosol formulation for inhalation therapy consisting essentially of a physiologically effective amount of particulate medicament, 1,1,1,2-tetrafluoroethane as propellant and up to 5% w/w based upon propellant of a polar co-solvent, which formulation is substantially free of surfactant.
Inventor(s): Akehurst; Rachel Ann (Ware, GB3), Taylor; Anthony James (Ware, GB3), Wyatt; David Andrew (Ware, GB3)
Assignee: Glaxo Group Limited (London, GB2)
Filing Date:May 30, 1995
Application Number:08/453,760
Claims:1. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy including a propellant which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve, and contains a pharmaceutical aerosol formulation consisting essentially of (i) particulate medicament, (ii) 1,1,1,2-tetrafluoroethane as propellant, and (iii) 0.01 to 5% w/w based upon the propellant of a polar cosolvent which is a C.sub.2-6 aliphatic alcohol or polyol or a mixture thereof, 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.

2. A canister as claimed in claim 1 wherein the polar cosolvent is present in an amount from 0.05 to 3% w/w based upon the propellant.

3. A canister as claimed in claim 2 wherein said medicament is an anti-allergic, a bronchodilator or an anti-inflammatory steroid.

4. A canister as claimed in claim 2 wherein said medicament is selected from the group consisting of salmeterol, salbutamol, fluticasone propionate, and physiologically acceptable salts and solvates thereof.

5. A canister as claimed in claim 2 wherein said medicament is beclomethasone dipropionate or a physiologically acceptable solvate thereof.

6. A canister as claimed in claim 2 wherein said medicament is selected from the group consisting of ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, isoetharine, tolubuterol, orciprenaline, (-)-4-amino-3,5-dichloro-.alpha.-[[[6-[2-(2-pyridinyl)ethoxy]hexyl]-amino] methyl]benzene-methanol and physiologically acceptable salts thereof.

7. A canister as claimed in claim 2 wherein the formulation contains two or more particulate medicaments.

8. A canister as claimed in claim 2 wherein the formulation contains a particulate bronchodilatory medicament and a particulate anti-inflammatory medicament.

9. A canister as claimed in claim 2 wherein the formulation contains salmeterol xinafoate in combination with fluticasone propionate.

10. A canister as claimed in claim 2 wherein the formulation is free of surfactant.

11. A canister as claimed in claim 2 wherein the polar cosolvent is ethanol.

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

13. A canister as claimed in claim 2 wherein the formulation has a respirable fraction of 20% or more by weight of the medicament.

14. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy including a propellant which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve, and contains a pharmaceutical aerosol formulation consisting of (i) particulate medicament, (ii) 1,1,1,2-tetrafluoroethane as propellant, and (iii) 0.01 to 5% w/w based upon the propellant of a polar cosolvent which is C.sub.2-6 aliphatic alcohol or polyol or a mixture thereof, 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.

15. A canister as claimed in claim 14 wherein the polar cosolvent is present in an amount from 0.05 to 3% w/w based upon the propellant.

16. A canister as claimed in claim 15 wherein said medicament is selected from the group consisting of salmeterol, salbutamol, fluticasone propionate, and physiologically acceptable salts and solvates thereof.

17. A canister as claimed in claim 15 wherein said medicament is beclomethasone dipropionate or a physiologically acceptable solvate thereof.

18. A canister as claimed in claim 15 wherein said medicament is selected from the group consisting of ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, isoetharine, tulobuterol, orciprenaline, (-)-4-amino-3,5-dichloro-.alpha.[[[6-[2-2(-pyridinyl)ethoxy]hexyl]-amino]m ethyl]benzene-methanol and physiologically acceptable salts thereof.

19. A canister as claimed in claim 15 wherein the formulation contains two or more particulate medicaments.

20. A canister as claimed in claim 15 wherein the formulation contains a particulate bronchodilatory medicament and a particulate anti-inflammatory medicament.

21. A canister as claimed in claim 15 wherein the formulation contains salmeterol xinafoate in combination with fluticasone propionate.

22. A canister as claimed in claim 15 wherein said medicament is an anti-allergic, a bronchodilator or an anti-inflammatory steroid.

23. A canister as claimed in claim 15 wherein the polar cosolvent is ethanol.

24. A canister as claimed in claim 15 wherein the medicament is present in an amount from 0.01 to 1 % w/w relative to the total weight of the formulation.

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

26. A canister as claimed in claim 2 wherein the polar cosolvent is ethanol.

27. A canister as claimed in claim 22 wherein the polar cosolvent is ethanol.

28. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy including a propellant which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve, and contains a pharmaceutical aerosol formulation consisting essentially of (i) particulate medicament, (ii) 1,1,1,2-tetrafluoroethane as propellant and (iii) 0.05 to 5% w/w based upon the propellant of a polar cosolvent being ethanol, isopropanol, propylene glycol or a mixture thereof, the particulate medicament being present in an amount from 0.01 to 1% 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.

29. A canister as claimed in claim 28 wherein the formulation is free of surfactant.

30. A canister as claimed in claim 28 wherein the formulation contains 0.05 to 3% w/w based upon the propellant of a polar cosolvent.

31. A canister as claimed in claim 29 wherein the formulation contains 0.05 to 3% w/w based upon the propellant of a polar cosolvent.

32. A canister as claimed in claim 28 wherein the polar cosolvent is ethanol.

33. A canister as claimed in claim 29 wherein the polar cosolvent is ethanol.

34. A canister as claimed in claim 28 wherein said medicament is formoterol or a physiologically acceptable salt thereof.

35. A canister as claimed in claim 29 wherein said medicament is formoterol or a physiologically acceptable salt thereof.

36. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy including a propellant which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve, and contains a pharmaceutical aerosol formulation consisting of (i) particulate medicament, (ii) 1,1,1,2-tetrafluoroethane as propellant and (iii) 0.05 to 5% w/w based upon the propellant of a polar cosolvent being ethanol, isopropanol, propylene glycol or a mixture thereof, the particulate medicament being present in an amount from 0.01 to 1 % w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

37. A canister as claimed in claim 36 wherein the formulation contains 0.05 to 3% w/w based upon the propellant of a polar cosolvent.

38. A canister as claimed in claim 36 wherein the polar cosolvent is ethanol.

39. A canister as claimed in claim 1 wherein the polar cosolvent is present in an amount of 0.05 to 5% w/w based upon the propellant.

40. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy including a propellant which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve, and contains a pharmaceutical aerosol formulation consisting of(i) a particulate medicament which is salmeterol or physiologically acceptable salts thereof, (ii) 1,1,1,2-tetrafluoroethane as propellant and (iii) 0.05 to 5% w/w based upon the propellant of a polar cosolvent being ethanol, isopropanol, propylene glycol or a mixture thereof, the particulate medicament being present in an amount from 0.01 to 1 % w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

41. A canister as claimed in claim 40 wherein the polar cosolvent is ethanol.

42. A canister as claimed in claim 40 wherein the salmeterol is in the form of salmeterol xinafoate.

43. A canister as claimed in claim 42 wherein the polar cosolvent is ethanol.

44. A canister as claimed in claim 2 wherein said medicament is an antiallergic medicament selected from the group consisting of cromoglycate, ketotifen, nedocromil, and physiologically acceptable salts thereof.

45. A canister as claimed in claim 2 wherein said medicament is an anti-inflammatory medicament selected from the group consisting of budesonide and triamcinolone acetonide.

46. A canister as claimed in claim 2 wherein said medicament is an anticholinergic medicament selected from the group consisting of ipratropium, atropine, oxitropium, and physiologically acceptable salts thereof.

47. A canister as claimed in claim 2 wherein said medicament is a xanthine selected from the group consisting of aminophylline, choline theophyllinate, lysine theophyllinate, theophylline, and physiologically acceptable salts thereof.

48. A canister as claimed in claim 15 wherein said medicament is an antiallergic medicament selected from the group consisting of cromoglycate, ketotifen, nedocromil, and physiologically acceptable salts thereof.

49. A canister as claimed in claim 15 wherein said medicament is an anti-inflammatory medicament selected from the group consisting of budesonide and triamcinolone acetonide.

50. A canister as claimed in claim 15 wherein said medicament is an anticholinergic medicament selected from the group consisting of ipratropium, atropine, oxitropium, and physiologically acceptable salts thereof.

51. A canister as claimed in claim 15 wherein said medicament is a xanthine selected from the group consisting of aminophylline, choline theophyllinate, lysine theophyllinate, theophylline, and physiologically acceptable salts thereof.
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