Details for Patent: 5,653,962
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| Title: | Aerosol formulations containing P134a and particulate medicaments |
| Abstract: | This invention relates to a pharmaceutical aerosol formulation containing a particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof end 1,1,1,2-tetrafluoroethane as propellant, which formulation is free of surfactant or has less than 0.0001 % w/w surfactant based on the weight of medicament. The formulation may contain a further particulate medicament which is salbutamol, beclomethasone dipropionate or a physiologically acceptable salt or solvate thereof. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation 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: | 08/444,928 |
| Claims: | 1. 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 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 formulation 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 formulation as claimed in claim 1 which has a respirable fraction of 20% or more by weight of particulate medicament. 4. A formulation as claimed in claim 1 wherein the salmeterol is in the form of its xinafoate salt. 5. 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 propellent, the particulate medicament being present in an amount of 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, which formulation is free of surfactant. 6. A pharmaceutical aerosol formulation consisting of 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 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. 7. A formulation as claimed in claim 5 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 formulation as claimed in claim 6 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 9. A formulation as claimed in claim 5 wherein the salmeterol is in the form of its xinafoate salt. 10. A formulation as claimed in claim 6 wherein the salmeterol is in the form of its xinafoate salt. 11. A formulation as claimed in claim 5 which has a respirable fraction of 20% or more by weight of particulate medicament. 12. A formulation as claimed in claim 6 which has a respirable fraction of 20% or more by weight of particulate medicament. 13. A pharmaceutical aerosol formulation consisting essentially of particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof, 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 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. 14. A pharmaceutical aerosol formulation consisting of particulate medicament consisting of salmeterol or a physiologically acceptable salt or solvate thereof, 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 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 formulation as claimed in claim 13 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 16. A formulation as claimed in claim 14 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 17. A formulation as claimed in claim 13 wherein the salmeterol is in the form of its xinafoate salt. 18. A formulation as claimed in claim 13 wherein the salmeterol is in the form of its xinafoate salt. 19. A formulation as claimed in claim 13 which has a respirable fraction of 20% or more by weight of the particulate medicaments. 20. A formulation as claimed in claim 14 which has a respirable fraction of 20% or more by weight of the particulate medicaments. 21. A formulation as claimed in claim 13 which formulation is free of surfactant. 22. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation of claim 1. 23. A method as claimed in claim 22 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 method as claimed in claim 22 wherein the salmeterol is in the form of its xinafoate salt. 25. A method as claimed in claim 22 which has a respirable fraction of 20% or more by weight of particulate medicament. 26. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation of claim 5. 27. A method as claimed in claim 26 wherein the salmeterol is in the form of its xinafoate salt. 28. A method as claimed in claim 26 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 29. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation of claim 6. 30. A method as claimed in claim 29 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 31. A method as claimed in claim 29 wherein the salmeterol is in the form of its xinafoate salt. 32. A method as claimed in claim 29 which has a respirable fraction of 20% or more by weight of particulate medicament. 33. A method of treating respiratory disorders which comprises administration by inhalation of the pharmaceutical aerosol formulation of claim 13. 34. A method as claimed in claim 33 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 35. A method as claimed in claim 33 wherein the salmeterol is in the form of its xinafoate salt. 36. A method as claimed in claim 33 which has a respirable fraction of 20% or more by weight of the particulate medicaments. 37. A method of treating respiratory disorders which comprises administration by inhalation of the pharmaceutical aerosol formulation of claim 14. 38. A method as claimed in claim 37 wherein particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation. 39. A method as claimed in claim 37 wherein the salmeterol is in the form of its xinafoate salt. |
