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Claims for Patent: 6,131,566

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Claims for Patent: 6,131,566

Title: Metered dose inhaler for albuterol
Abstract:A metered dose inhaler having all or part of its internal surfaces coated with one or more fluorocarbon polymers, optimally a blend of one or more fluorocarbon polymers in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formation comprising albuterol or a physiologically acceptable salt thereof and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents or one or more excipients.
Inventor(s): Ashurst; Ian Carl (Ware, GB), Herman; Craig Steven (Raleigh, NC), Li-Bovet; Li (Scotch Plains, NJ), Riebe; Michael Thomas (Raleigh, NC)
Assignee: Glaxo Wellcome Inc. (Research Triangle Park, NC) Glaxo Group Limited (Greenford Middlesex, GB)
Application Number:08/831,268
Patent Claims: 1. A metered dose inhaler having part or all of its internal surfaces coated with a polymer blend comprising one or more fluorocarbon polymers in combination with one or more non-fluorocarbon polymers, containing an inhalation drug formulation comprising albuterol, or a physiologically acceptable salt thereof, and a fluorocarbon propellant.

2. An inhaler according to claim 1, wherein said drug formulation further comprises a surfactant.

3. An inhaler according to claim 1, wherein said drug formulation further comprises a polar cosolvent.

4. An inhaler according to claim 3, wherein said drug formulation comprises 0.01 to 5% w/w based upon propellant of a polar cosolvent.

5. An inhaler according to claim 4, wherein said formulation is substantially free of a surfactant.

6. An inhaler according to claim 1, wherein said drug formulation comprises albuterol or a physiologically acceptable salt thereof in combination with an anti-inflammatory steroid or an antiallergic.

7. An inhaler according to claim 6, wherein said anti-inflammatory steroid is beclomethasone dipropionate or a physiologically acceptable solvate thereof.

8. An inhaler according to claim 1, wherein said drug formulation consists essentially of albuterol or a physiologically acceptable salt thereof and a fluorocarbon propellant.

9. An inhaler according to claim 1, wherein said drug formulation consists essentially of albuterol or a physiologically acceptable salt thereof in combination with an anti-inflammatory steroid or an antiallergic and a fluorocarbon propellant.

10. An inhaler according to claim 9, wherein said anti-inflammatory steroid is beclomethasone dipropionate or a physiologically acceptable solvate thereof.

11. An inhaler according to claim 1, wherein said drug formulation consists of albuterol or a physiologically acceptable salt thereof and a fluorocarbon propellant.

12. An inhaler according to claim 1, wherein said albuterol is in the form of the sulfate salt.

13. An inhaler according to claim 1, wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane, or 1,1,1,2,3,3,3-heptafluoro-n-propane or a mixture thereof.

14. An inhaler according to claim 13, wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane.

15. An inhaler according to claim 1, comprising a can made of metal wherein part or all of the internal metallic surfaces are coated.

16. An inhaler according to claim 15, wherein said coating is applied to said internal surface of a preformed can.

17. An inhaler according to claim 15, wherein said coating is applied by spray coating said polymer blend.

18. An inhaler according to claim 15, wherein said coating is applied by spray coating said polymer blend on the internal metallic surface of said can and curing said coating after it is sprayed.

19. An inhaler according to claim 15, wherein the metal is aluminum or an alloy thereof.

20. An inhaler according to claim 19, wherein said one or more fluorocarbon polymers is blended with a non-fluorocarbon polymer selected from polyamideimide and polyethersulphone.

21. An inhaler according to claim 1, wherein said one or more fluorocarbon polymers is a perfluorocarbon polymer.

22. An inhaler according to claim 21, wherein said one or more fluorocarbon polymers are selected from the group consisting of polytetrafluoroethylene, perfluoroalkoxy fluorocarbon polymer, fluorinated ethylene propylene copolymer and mixtures thereof.

23. An inhaler according to claim 22, wherein said fluorinated polymer is polytetrafluoroethylene.

24. A metered dose inhaler system comprising a metered dose inhaler according to claim 1, fitted into suitable channeling device for oral or nasal inhalation of the drug formulation.

25. A method for the treatment of a respiratory disorder comprising the step of administering an effective amount of an aerosol composition to a patient from a a metered dose inhaler system according to claim 24.

26. An inhaler according to claim 1, wherein the fluorocarbon propellant is 1,1,1,2,3,3,3-heptafluoro-n-propane.

27. An inhaler according to claim 1, wherein said fluorocarbon polymer comprises monomeric units made from one or more monomers selected from the group consisting of tetrafluoroethylene, hexafluoropropylene, perfluoroalkoxyalkylene, and vinylidene fluoride.

28. An inhaler according to claim 1, wherein said non-fluorinated polymer is selected from the group consisting of a polyamide, a polyimide, a polyamideimide, a polyethersulfone, a polyphenylene sulfide and an amine-formaldehyde thermosetting resin.

29. An inhaler according to claim 28, wherein said non-fluorinated polymer is a polyethersulfone.

30. An inhaler according to claim 1, wherein said blend comprises polytetrafluoroethylene and polyethersulfone.

31. An inhaler according to claim 1, wherein said blend consists of polytetrafluoroethylene and polyethersulfone.

32. An inhaler according to claim 1, wherein said fluorinated polymer is made from monomeric units comprising perfluoroalkoxyalkylene.

33. An inhaler according to claim 1, wherein said fluorinated polymer is made from monomeric units comprising perfluorinated ethylene propylene.

34. An inhaler according to claim 1, wherein the thickness of said coating is 1 .mu.m to 1 mm.

35. An inhaler according to claim 1, wherein the thickness of said coating is 1 .mu.m to 100 .mu.m.

36. An inhaler according to claim 1, wherein the thickness of said coating is 1 .mu.m to 25 .mu.m.

37. A metered dose inhaler having part or all of its internal surfaces coated with a blend of a fluorinated polymer and a non-fluorinated polymer containing a drug formulation comprising albuterol or a physiologically acceptable salt thereof in the form of particles having a particle size less than 100 microns in an amount of 0.005 to 10% by weight relative to the total weight of the formulation and a fluorocarbon propellant which is 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane or a mixture thereof.

38. An inhaler according to claim 37, wherein said fluorocarbon propellant comprises 1,1,1,2-tetrafluoroethane.

39. An inhaler according to claim 37, wherein said drug formulation consists of said albuterol or a physiologically acceptable salt thereof and said fluorocarbon propellant.

40. An inhaler according to claim 39, wherein said fluorocarbon propellant consists of 1,1,1,2-tetrafluoroethane.

41. A method for delivering a drug formulation to a patient comprising the step of administering an effective amount of an aerosol composition containing said drug formulation to a patient from said metered dose inhaler of claim 37.

42. An inhaler according to claim 37, wherein said blend is a blend of polytetrafluoroethylene and polyethersulphone.

43. An inhaler according to claim 42, wherein said drug formulation comprises albuterol sulfate and 1,1,1,2-tetrafluoroethane.

44. An inhaler according to claim 42, wherein said drug formulation consists of albuterol sulfate and 1,1,1,2-tetrafluoroethane.

45. An inhaler according to claim 42, wherein said drug formulation comprises albuterol sulfate, beclomethasone dipropionate and 1,1,1,2-tetrafluoroethane.

46. An inhaler according to claim 42, wherein said drug formulation consists of albuterol sulfate, beclomethasone dipropionate and 1,1,1,2-tetrafluoroethane.

47. A metered dose inhaler, comprising:

a can having a mouth, said can having on its internal surface a coating having a thickness of 1 .mu.m to 1 mm comprising a blend of a fluorinated polymer made from one or more monomeric units selected from the group consisting of tetrafluoroethylene, hexafluoropropylene, perfluoroalkoxyalkylene, and vinylidene fluoride and a non-fluorinated polymer selected from the group consisting of a polyamide, a polyimide, a polyamideimide, a polyethersulfone, a polyphenylene sulfide and an amine-formaldehyde thermosetting resin;

a cap covering said mouth of said can;

a drug metering value situated in said cap; and

an inhalation drug formulation comprising 0.005 to 10% by weight of albuterol or a physiologically acceptable salt thereof relative to the total weight of said drug formulation, said albuterol or a physiologically acceptable salt thereof having a particle size less than 100 microns and a fluorocarbon propellant which is 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane or a mixture thereof.

48. An inhaler according to claim 47, which is prepared by spray coating said coating on said internal surface of said can.

49. An inhaler according to claim 48, wherein said can is a metal can.

50. An inhaler according to claim 49, wherein said metal can is formed of aluminum or an aluminum alloy.

51. An inhaler according to claim 50, wherein said albuterol or a physiologically acceptable salt thereof is albuterol sulfate.

52. An inhaler according to claim 48, wherein said coating is cured after it is coated on said internal surface.

53. An inhaler according to claim 52, wherein a primer layer is interposed between said coating and said internal surface of said can.

54. An inhaler according to claim 52, which does not contain a primer layer interposed between said coating and said internal surface of said can.

55. An inhaler according to claim 48, wherein said fluorinated polymer is a perfluorinated polymer.

56. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate and 1,1,1,2-tetrafluoroethane.

57. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate, 1,1,1,2-tetrafluoroethane and a polar cosolvent.

58. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate, 1,1,1,2-tetrafluoroethane and a surfactant.

59. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate, 1,1,1,2-tetrafluoroethane, a polar cosolvent and a surfactant.

60. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate and 1,1,1,2,3,3,3-heptafluoro-n-propane.

61. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate, 1,1,1,2,3,3,3-heptafluoro-n-propane and a polar cosolvent.

62. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate, 1,1,1,2,3,3,3-heptafluoro-n-propane and a surfactant.

63. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting essentially of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting essentially of albuterol sulfate, 1,1,1,2,3,3,3-heptafluoro-n-propane, a polar cosolvent and a surfactant.

64. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting of albuterol sulfate and 1,1,1,2-tetrafluoroethane.

65. A metered dose inhaler having all or part of its internal surfaces coated with a polymer blend consisting of polytetrafluoroethylene and polyethersulfone and containing an inhalation drug formulation consisting of albuterol sulfate and 1,1,1,2,3,3,3-heptafluoro-n-propane.
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