Details for Patent: 5,683,676
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| Title: | Canister containing aerosol formulations containing P134a and particulate medicaments |
| 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 salmeterol 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) |
| Filing Date: | May 19, 1995 |
| Application Number: | 08/444,926 |
| Claims: | 1. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy 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 salmeterol or a physiologically acceptable salt or 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 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. 2. 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. 3. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy 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 which is salmeterol or a physiologically acceptable salt or 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. 4. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is a plastics-coated aluminum can and is closed with a metering valve and contains a pharmaceutical aerosol suspension formulation consisting essentially of a particulate medicament which is salmeterol xinafoate 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 of 0.01 to 1% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns. 5. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy 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 salmeterol or a physiologically acceptable salt or solvate thereof and a particulate medicament selected from the group consisting of 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 upon 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. 6. A canister suitable for delivering a pharmaceutical aerosol formulation for inhalation therapy 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 which is salmeterol or a physiologically acceptable salt or solvate thereof and a particulate medicament selected from the group consisting of 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. 7. A canister as claimed in claim 5 wherein the formulation is free of surfactant. 8. A canister as claimed in claim 5 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 9. A canister as claimed in claim 6 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 10. A canister as claimed in claim 5 wherein the salmeterol is in the form of its xinafoate salt. 11. A canister as claimed in claim 6 wherein the salmeterol is in the form of its xinafoate salt. 12. A canister as claimed in claim 5 wherein the formulation has a respirable fraction of 20% or more by weight of the particulate medicaments. 13. A canister as claimed in claim 6 wherein the formulation has a respirable fraction of 20% or more by weight of the particulate medicaments. 14. A canister as claimed in claim 1 wherein the formulation is free of surfactant. 15. A canister as claimed in claim 1 wherein the container is plastics-coated, lacquer-coated or anodized. 16. A canister as claimed in claim 1 wherein the container is a metal can. 17. A canister as claimed in claim 1 wherein the container is a metal can which is plastics-coated. 18. A canister as claimed in claim 1 wherein the container is an aluminum can. 19. A canister as claimed in claim 1 wherein the container is an aluminum can which is plastics-coated. 20. A canister as claimed in claim 1 wherein the salmeterol is in the form of its xinafoate salt. 21. 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. 22. A canister as claimed in claim 3 wherein the container is plastics-coated, lacquer-coated or anodized. 23. A canister as claimed in claim 3 wherein the container is a metal can. 24. A canister as claimed in claim 3 wherein the container is a metal can which is plastics-coated. 25. A canister as claimed in claim 3 wherein the container is an aluminum can. 26. A canister as claimed in claim 3 wherein the container is an aluminum can which is plastics-coated. 27. A canister as claimed in claim 3 wherein the salmeterol or physiologically acceptable salt or solvate thereof is present in an amount of 0.01 to 1% w/w based on total weight of the formulation. 28. A canister as claimed in claim 3 wherein the salmeterol is in the form of its xinafoate salt. 29. A canister as claimed in claim 3 wherein the formulation has a respirable fraction of 20% or more by weight of salmeterol or physiologically acceptable salt or solvate thereof. 30. A metered dose inhaler which comprises a canister as claimed in claim 3 fitted into a channelling device for nasal or oral inhalation of the pharmaceutical aerosol formulation. 31. A canister as claimed in claim 1 wherein the pharmaceutical aerosol formulation is in a form for inhalation into lungs of a patient. 32. A canister as claimed in claim 3 wherein the pharmaceutical aerosol formulation is in a form for inhalation into lungs of a patient. |
