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Claims for Patent: 6,143,277

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Claims for Patent: 6,143,277

Title: Metered dose inhaler for salmeterol
Abstract:A metered dose inhaler having part or all of its internal metallic surfaces coated with one or more fluorocarbon polymers, in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formulation comprising salmeterol, or a salt thereof, and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents and one or more excipients.
Inventor(s): Ashurst; Ian C. (Ware, GB), Herman; Craig S. (Raleigh, NC), Li; Li (Scotch Plains, NJ), Riebe; Michael T. (Raleigh, NC)
Assignee: Glaxo Wellcome Inc. (Research Triangle Park, NC) Glaxo Group Limited (Greenford, GB)
Application Number:08/770,533
Patent Claims: 1. A metered dose inhaler containing therein an inhalation drug formulation comprising salmeterol, or a physiologically acceptable salt thereof, and a fluorocarbon propellant comprising 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoro-n-propane or a mixture thereof, wherein said metered dose inhaler has part or all of its internal surfaces coated with a polymer blend comprising (i) one or more fluorocarbon polymers comprising monomeric units made from one or more monomers selected from the group consisting of tetrafluoroethylene, hexafluoropropylene, perfluoroalkoxyalkylene, and vinylidene fluoride in combination with (ii) one or more non-fluorocarbon polymers selected from the group consisting of a polyamide, a polyimide, a polyamideimide, a polyethersulphone, a polyphenylene sulfide and an amine-formaldehyde thermosetting resin.

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 1, wherein said drug formulation comprises 0.01 to 5% w/w based upon propellant of a polar cosolvent.

5. An inhaler according to claim 1, wherein said drug formulation comprises salmeterol or a physiologically acceptable salt thereof in combination with an antiinflammatory steroid or an antiallergic.

6. An inhaler according to claim 5, wherein said drug formulation comprises salmeterol xinafoate in combination with fluticasone propionate.

7. An inhaler according to 1, wherein said drug formulation consists essentially of salmeterol or a physiologically acceptable salt thereof, optionally in combination with one or more other pharmacologically active agents, and a fluorocarbon propellant.

8. An inhaler according to claim 7, wherein said drug formulation consists essentially of salmeterol or a physiologically acceptable salt thereof in combination with an antiinflammatory steroid or an antiallergic and a fluorocarbon propellant.

9. An inhaler according to claim 8, wherein said drug formulation consists essentially of salmeterol or a physiologically acceptable salt thereof in combination with fluticasone propionate or a physiologically acceptable solvate thereof and a fluorocarbon propellant.

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

11. An inhaler according to claim 1, wherein the salmeterol is in the form of the xinafoate salt.

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

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

14. An inhaler according to claim 13, wherein the metal is aluminium or an alloy therein.

15. An inhaler according to claim 1, wherein said fluorocarbon polymer is a perfluorocarbon polymer.

16. An inhaler according to claim 15, wherein said fluorocarbon polymer is selected from the group consisting of polytetrafluoroethylene, perfluoroalkoxy fluorocarbon polymer, perfluorinated ethylene propylene copolymer and mixtures thereof.

17. An inhaler according to claim 1, wherein said fluorocarbon polymer is in combination with a non-fluorocarbon polymer selected from polyamideimide and polyethersulphone.

18. An inhaler according to claim 1, comprising an ellipsoidal base.

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

20. 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 metered dose inhaler system according to claim 19.

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

22. The metered dose inhaler of claim 1, wherein said non-fluorinated polymer is a polyethersulphone.

23. The metered dose inhaler of claim 1 or 22, wherein said fluorinated polymer is polytetrafluoroethylene.

24. The metered dose inhaler of claim 1, wherein said fluorinated polymer is made from monomeric units comprising a perfluoroalkoxyalkylene.

25. The metered dose inhaler of claim 1, wherein said fluorinated polymer is made from monomeric units comprising perfluorinated ethylene propylene.

26. The metered dose inhaler of claim 1, wherein the thickness of said coating is 1 .mu.m to 1 mm.

27. The metered dose inhaler of claim 1, wherein the thickness of said coating is 1 .mu.m to 100 .mu.m.

28. The metered dose inhaler of claim 1, wherein the thickness of said coating is 1 .mu.m to 25 .mu.m.

29. The metered dose inhaler of claim 13, wherein said coating is applied to said internal surface of a preformed can.

30. The metered dose inhaler of claim 13, wherein said coating is applied by spray coating said polymer blend.

31. The metered dose inhaler of claim 13, wherein said coating is applied by spray coating said polymer blend on the internal metallic surface of said can made of metal and curing said coating after it is sprayed.

32. A metered dose inhaler containing therein an inhalation drug formulation comprising salmeterol, 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, wherein said metered dose inhaler has part or all of its internal surfaces coated with a blend of (i) one or more fluorinated polymers which is made of multiples of one or more monomeric units selected from the group consisting of tetrafluoroethylene, perfluorinated ethylene propylene, perfluoropropyl vinyl ether, ethylene tetrafluoroethylene, vinylidene fluoride and chlorinated ethylene tetrafluoroethylene and (ii) a non-fluorinated polymer selected from the group consisting of a polyamide, a polyimide, a polyamideimide, a polyethersulphone, a polyphenylene sulfide and an amine-formaldehyde thermosetting resin.

33. The metered dose inhaler of claim 32, wherein said drug formulation consists of said salmeterol or a physiologically acceptable salt thereof and said fluorocarbon propellant.

34. 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 32 or 33.

35. A metered dose inhaler containing therein an inhalation drug formulation comprising 0.005 to 10% by weight of salmeterol or a physiologically acceptable salt thereof relative to the total weight of said drug formulation, said salmeterol 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, comprising:

a metal 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 one or more fluorinated polymers which is made of multiples of one or more monomeric units selected from the group consisting of tetrafluoroethylene, perfluorinated ethylene propylene, perfluoropropyl vinyl ether, ethylene tetrafluoroethylene, vinylidene fluoride and chlorinated ethylene tetrafluoroethylene and a non-fluorinated polymer selected from the group consisting of a polyamide, a polyamideimide, a polyethersulphone, a polyphenylene sulfide and an amine-formaldehyde thermosetting resin;

a cap covering said mouth of said can; and

a drug metering value situated in said cap.

36. The metered dose inhaler of claim 35, which is prepared by spray coating said coating on said internal surface of said can.

37. The metered dose inhaler of claim 36, wherein said coating is cured after it is coated on said internal surface.

38. The metered dose inhaler of claim 36, wherein said fluorinated polymer is a perfluorinated polymer.

39. The metered dose inhaler of claim 36 or 37, wherein a primer layer is interposed between said coating and said internal surface of said can.

40. The metered dose inhaler of claim 36 or 37, which does not contain a primer layer interposed between said coating and said internal surface of said can.

41. The metered dose inhaler of claim 32 or 35, wherein said blend is a blend of polytetrafluoroethylene and polyethersulphone.

42. The metered dose inhaler of claim 41, wherein said drug formulation comprises salmeterol xinafoate and 1,1,1,2-tetrafluoroethane.

43. The metered dose inhaler of claim 41, wherein said drug formulation consists of salmerterol xinafoate and 1,1,1,2-tetrafluoroethane.

44. The metered dose inhaler of claim 41, wherein said drug formulation comprises salmeterol xinafoate, fluticasone propionate and 1,1,1,2-tetrafluoroethane.

45. The metered dose inhaler of claim 41, wherein said drug formulation consists of salmeterol xinafoate, fluticasone propionate and 1,1,1,2-tetrafluoroethane.
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