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Details for Patent: 5,653,962

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Details for Patent: 5,653,962

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.
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