Metered dose inhaler for salemeterol xinafoate

• US 20040050960A1
• Filed: 10/15/2003
• Published: 03/18/2004
• Est. Priority Date: 12/22/2000
• Status: Abandoned Application

• Current Assignee: Smithkline Beecham Corporation (Smithkline Beecham PLC)
• Original Assignee: Smithkline Beecham Corporation (Smithkline Beecham PLC)
• Inventors: Warby, Richard, Godfrey, Anne Pauline
• Application Number:
  US10/451,444
• Publication Number:
  US 20040050960A1
• Time in Patent Office: Days
• US Class Current: 239/302
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: B65D 77/003 Articles enclosed in rigid or semi-rigid containers, the whole being wrapped
• CPC Class Codes: B65D 81/266 for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence
• CPC Class Codes: B65D 83/38 Details of the container body pressure relief devices B65D83/70
• CPC Class Codes: B65D 83/54 Metering valves ; Metering valve assemblies
• CPC Class Codes: B65D 83/752 characterised by the use of specific products or propellants

Abstract

A container that includes a canister sealed with a metering valve, having a metering chamber is described. The metering valve includes one or more sealing gaskets substantially constructed from a polymer of EPDM and the metering chamber surface presents a substantially fluorinated surface to a pharmaceutical aerosol formulation within the container. Metered dose inhalers that include the container are also described, as are packages that include the metered dose inhalers. Methods of treating various diseases, such as asthma and chronic obstructive pulmonary disease, using the metered dose inhalers are also described.

Claims

1. A container comprising a canister sealed with a metering valve, having a metering chamber, which contains a pharmaceutical aerosol formulation consisting essentially of

(A) particulate salmeterol xinafoate optionally in combination with another drug useful in inhalation therapy, suspended in

(B) a liquefied propellant gas comprising 1,1,1,2,3,3,3-heptafluoro-n-propane, 1,1,1,2-tetrafluoroethane or a mixture thereof;

wherein the formulation is substantially free of surfactant and components having polarity higher than the liquefied propellant gas;

said valve characterised in that it contains one or more sealing gaskets substantially constructed from of a polymer of EPDM and the metering chamber surface presents a substantially fluorinated surface to the formulation.

2. A container as claimed in claim 1 wherein the liquefied propellant gas is 1,1,1,2-tetrafluoroethane.

3. A container as claimed in claim 1 or claim 2 wherein the another drug useful in inhalation therapy is fluticasone propionate or ipratropium bromide.

4. A container as claimed in claim 1 or claim 2 wherein salmeterol xinafoate is the only medicament.

5. A container according to any one of claims 1 to 4 wherein the valve is sealed to the canister by means of a neck sealing gasket which is substantially constructed from a polymer of EPDM.

6. A container according to any one of claims 1 to 5 wherein the metering valve includes a metering chamber having an upper and a lower sealing gasket and a valve stem characterised in that said two sealing gaskets are substantially constructed from a polymer of EPDM.

7. A container according to any one of claims 1 to 6 wherein the metering chamber is constructed from a plastics material.

8. A container according to claim 7 wherein the plastics material is nylon, PBT or acetal.

9. A container according to any one of claims 1 to 8 wherein the metering chamber is surface treated so as to present a substantially fluorinated surface to the formulation.

10. A container according to claim 9 wherein the surface treatment comprises a process of plasma coating with a C_1-10perfluoroalkane.

11. A container according to claim 7 wherein the metering chamber is constructed from a material selected from the group consisting of a polyethylenetetrafluoroethylene, a polyvinyldienefluoride, a polyperfluoroalkoxyalkane, a polychlorotrifluoroethylene, a fluorinated polyethylene propylene, a copolymer of a polytetrafluoroethylene and a polyperfluoroalkoxyalkane, a copolymer of a polytetrafluoroethylene and a polyhexafluoropropylene, a copolymer of a polyvinyldienefluoride and a polyhexafluoropropylene, a copolymer of a polytetrafluoroethylene and a polyperfluoro(propyl vinyl ether);

a blend of a polytetrafluoroethylene, a polyhexafluoropropylene a polyvinylidene fluoride, blends thereof and combinations thereof.

12. A container according to any one of claims 1 to 6 wherein the metering chamber is composed of a metallic material.

13. A container according to claim 12 wherein the metallic material is aluminium or stainless steel.

14. A container according to claim 12 or 13 wherein the metering chamber is surface treated so as to present a substantially fluorinated surface to the formulation.

15. A container according to claim 14 wherein the surface treatment comprises a process of applying a coating of a fluorocarbon polymer optionally in combination with a non-fluorocarbon polymer.

16. A container according to claim 14 or claim 15 wherein fluorocarbon polymer is selected from FEP and PTFE.

17. A container according to any one of claims 14 to 16 wherein the coating is a coating of FEP.

18. A container according to any one of claims 14 to 16 wherein the coating is a coating of a blend of PTFE and PES.

19. A container according to any one of claims 1 to 18 wherein the canister is composed of aluminium.

20. A container according to claim 19 wherein the canister is surface treated so as to present a substantially fluorinated surface to the formulation.

21. A container according to claim 20 wherein the canister is surface treated by coating with a fluorocarbon polymer optionally in combination with a non-fluorocarbon polymer.

22. A container according to claim 20 or claim 21 wherein fluorocarbon polymer is selected from FEP and PTFE.

23. A container according to any one of claims 20 to 22 wherein the coating is a coating of FEP.

24. A container according to any one of claims 20 to 22 wherein the coating is a coating of a blend of PTFE and PES.

25. A metered dose inhaler comprising a container according to any one of claims 1 to 24 fitted with a suitable channelling device.

26. A method of treatment of asthma or COPD which comprises use of a metered dose inhaler according to claim 25 by a patient.

27. A package comprising a metered dose inhaler according to claim 25 contained within a flexible wrapper said wrapper composed of a material which is substantially permeable to evacuation of propellant gas and substantially impermeable to intrusion of atmospheric moisture.

28. A package according to claim 27 characterised in the flexible wrapper also contains within it a desiccant material.

29. A package according to claim 28 characterised in the can contains within it a desiccant material.

30. A container suitable for containing a pharmaceutical aerosol formulation comprising a canister sealed with a metering valve, said valve comprising a metering chamber having an upper and a lower sealing gasket and a valve stem, wherein the valve is sealed to the canister by means of a neck sealing gasket, characterised in that at least one gasket is substantially constructed from a polymer of EPDM and the metering chamber surface presents a substantially fluorinated surface to the formulation.

31. A container suitable for containing a pharmaceutical aerosol formulation according to claim 30 wherein the upper, lower and neck sealing gaskets are substantially constructed from a polymer of EPDM.

32. A container suitable for containing a pharmaceutical aerosol formulation according to claim 30 or claim 31 wherein the metering chamber is surface treated so as to present a substantially fluorinated surface to the formulation.

33. A container according to claim 32 wherein the surface treatment comprises a process of plasma coating with a C_1-10perfluoroalkane.

34. A container according to any one of claims 30 to 33 wherein the metering chamber is constructed from a plastics material.

35. A container according to claim 34 wherein the plastics material is nylon, PBT or acetal.

36. A container according to any one of claims 30 to 35 wherein the canister is composed of aluminium.

37. A container according to claim 36 wherein the canister is surface treated so as to present a substantially fluorinated surface to the formulation.

38. A container according to claim 37 wherein the canister is surface treated by coating with a fluorocarbon polymer optionally in combination with a non-fluorocarbon polymer.

39. A container according to any one of claims 30 to 38 which contains a pharmaceutical aerosol formulation comprising a particulate medicament and a liquefied propellant gas of 1,1,1,2,3,3,3-heptafluoro-n-propane, 1,1,1,2-tetrafluoroethane or mixtures thereof.

40. A container according to claim 39 wherein the propellant gas is 1,1,1,2-tetrafluoroethane.

41. A container according to claim 39 or claim 40 wherein the particulate medicament is selected from salmeterol xinafoate, fluticasone propionate, albuterol or a salt thereof, beclomethasone dipropionate, formoterol or a salt thereof, ipratropium bromide, budesonide, sodium cromoglycate and combinations thereof.

42. A container according to claim 41 wherein the particulate medicament is salmeterol xinafoate optionally in combination with fluticasone propionate.