Claims for Patent: 5,674,472

Summary for Patent: 5,674,472

Title:	Canisters containing aerosol formulations containing P134a and fluticasone propionate
Abstract:	The present invention relates to canisters suitable for delivering a pharmaceutical aerosol formulation 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 a 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 the 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. A further particulate medicament may also be present in the pharmaceutical aerosol formulation.
Inventor(s):	Akehurst; Rachel Ann (Ware, GB3), Taylor; Anthony James (Ware, GB3), Wyatt; David Andrew (Ware, GB3)
Assignee:	Glaxo Group Limited (London, GB)
Application Number:	08/444,919
Patent Claims:	1. A canister suitable for delivering a pharmaceutical aerosol formulation 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 a 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 the 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 canister as claimed in claim 1 wherein the container is plastics coated, lacquer-coated or anodized. 3. A canister as claimed in claim 1 wherein the container is a metal can. 4. A canister as claimed in claim 1 wherein the container is a metal can which is plastics-coated. 5. A canister as claimed in claim 1 wherein the container is an aluminum can. 6. A canister as claimed in claim 1 wherein the container is an aluminum can which is plastics-coated. 7. A canister 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. 8. A canister as claimed in claim 1 wherein the formulation has a respirable fraction of 20% or more by weight of the particulate medicament. 9. A canister suitable for delivering a pharmaceutical aerosol formulation 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 a 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 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. 10. A canister as claimed in claim 9 wherein the container is plastics coated, lacquer-coated or anodized. 11. A canister as claimed in claim 9 wherein the container is a metal can. 12. A canister as claimed in claim 9 wherein the container is a metal can which is plastics-coated. 13. A canister as claimed in claim 9 wherein the container is an aluminum can. 14. A canister as claimed in claim 9 wherein the container is an aluminum can which is plastics-coated. 15. A canister as claimed in claim 9 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 16. A canister suitable for delivering a pharmaceutical aerosol formulation 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 which is fluticasone propionate or a physiologically acceptable solvate thereof; (ii) a particulate medicament selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof; and (iii) 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based on the weight of the 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. 17. A canister suitable for delivering a pharmaceutical aerosol formulation which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve and contains (pharmaceutical aerosol formulation consisting of particulate medicament consisting of; (i) fluticasone propionate or a physiologically acceptable solvate thereof; (ii) a particulate medicaments selected from the group consisting of salmeterol, salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof; and (iii) 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. 18. A canister as claimed in claim 16 or claim 17 wherein the container is plastics-coated, lacquer-coated or anodized. 19. A canister as claimed in claim 16 or claim 17 wherein the container is a metal can. 20. A canister as claimed in claim 16 or claim 17 wherein the container is a metal can which is plastics-coated. 21. A canister as claimed in claim 16 or claim 17 wherein the container is an aluminum can. 22. A canister as claimed in claim 16 or claim 17 wherein the container is an aluminum can, which is plastics-coated. 23. A canister as claimed in claim 16 or claim 17 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 canister as claimed in claim 16 or claim 17 which contains fluticasone propionate or a physiologically acceptable solvate thereof and salmeterol or salbutamol or a physiologically acceptable salt thereof. 25. A canister as claimed in claim 16 or claim 17 which contains fluticasone propionate and salmeterol xinafoate. 26. A metered dose inhaler which comprises a canister as claimed in claim 1 fitted into a channelling device for nasal or oral inhalation of the pharmaceutical aerosol formulation. 27. A metered dose inhaler which comprises a canister as claimed in claim 9 fitted into a channelling device for nasal or oral inhalation of the pharmaceutical aerosol formulation. 28. A metered dose inhaler which comprises a canister as claimed in claim 16 fitted into a suitable channeling device for nasal or oral inhalation of the pharmaceutical aerosol formulation. 29. A metered dose inhaler which comprises a canister as claimed in claim 17 fitted into a suitable channeling device for nasal or oral inhalation of the pharmaceutical aerosol formulation. 30. A canister as claimed in claim 16 wherein the formulation has a respirable fraction of 20% or more by weight of the particulate medicament. 31. A canister suitable for delivering a pharmaceutical aerosol formulation 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 particulate medicament which is fluticasone propionate, and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based on the weight of the medicament, 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. 32. A canister as claimed in claim 31 wherein the container comprises an aluminum can which is plastics coated. 33. A canister as claimed in claim 31 wherein the formulation is free of surfactant. 34. A canister suitable for delivering a pharmaceutical aerosol formulation 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 particulate medicaments which are fluticasone propionate and salmeterol xinafoate, and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based on the weight of the medicament, the particulate medicaments 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. 35. A canister as claimed in claim 34 wherein the container comprises an aluminum can which is plastics coated. 36. A canister as claimed in claim 34 wherein the formulation is free of surfactant. 37. A canister as claimed in claim 1 wherein the formulation is free of surfactant. 38. A canister as claimed in claim 16 wherein the formulation is free of surfactant. 39. A canister as claimed in claim 1 wherein the particulate medicament is fluticasone propionate. 40. A canister as claimed in claim 9 wherein the particulate medicament is fluticasone propionate. 41. A canister as claimed in claim 1 wherein the formulation is in a form suitable for inhalation into the lungs of a patient. 42. A canister as claimed in claim 9 wherein the formulation is in a form suitable for inhalation into the lungs of a patient. 43. A canister as claimed in claim 16 wherein the formulation is in a form suitable for inhalation into the lungs of a patient. 44. A canister as claimed in claim 17 wherein the formulation is in a form suitable for inhalation into the lungs of a patient.