Medicament container, a medicament dispensing kit for administering medication and a method for packaging the same

• US 7,708,719 B2
• Filed: 11/01/2002
• Issued: 05/04/2010
• Est. Priority Date: 11/02/2001
• Status: Active Grant

• Current Assignee: Meridian Medical Technologies Incorporated
• Original Assignee: Meridian Medical Technologies Incorporated
• Inventors: Mesa, C. Michael, Wilmot, John G.
• Primary Examiner(s): Desanto; Matthew F
• Application Number:
  US10/285,692
• Publication Number:
  US 20030106824A1
• Time in Patent Office: 2,741 Days
• Field of Search: 604/96, 604/131, 604 82- 92, 604/134, 604/135, 604/140, 604/181, 604/187, 604200-207, 604232-236, 206/364, 206/438
• US Class Current: 604/236
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2462 by displacing occluding plugs
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: B65D 81/266 for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence

Abstract

A medicament container, medicament dispensing kit and packaging process that minimizes exposure of the medication to oxygen to prevent degradation of the medication are disclosed.

Claims

1. A medicament dispensing kit for administering a predetermined dose of medication, the medicament dispensing kit comprising:

a predetermined dose of medication;

a medicament container containing the predetermined dose of medication, the container comprising a front end sealing assembly that seals the dose of medication in the container, the front end sealing assembly having a passageway operable to vent gases from the container during a container filling operation and operable to pass the predetermined dose of medication there through from the container during a medication dispensing operation, the front end sealing assembly having a first end and a second end, the passageway formed in an exterior surface of the front end sealing assembly and extending along the exterior surface from the first end partially toward the second end;

a dispensing assembly configured to receive the medicament container therein, wherein the dispensing assembly dispenses the predetermined dose of medication upon activation by a user;

a gas absorbing component; and

a sealed package forming a sealed interior compartment flushed with an inert gas to remove oxygen, wherein the sealed interior compartment contains the medicament container having the predetermined dose of medication located therein, the dispensing assembly, the inert gas, and the gas absorbing component.

2. The dispensing kit according to claim 1, wherein the medicament container comprises:

a cartridge assembly for receiving the predetermined dose of medication and the front end sealing assembly; and

an internal sealing assembly positioned in the cartridge assembly.

3. The dispensing kit according to claim 2, wherein at least one sealing assembly is formed from one of an oxygen absorbing material, an oxygen barrier material, and an oxygen permeable material.

4. The dispensing kit according to claim 3, wherein the oxygen absorbing material and the oxygen barrier material are rubber.

5. The dispensing kit according to claim 2, wherein the predetermined dose of medication is sealed within the cartridge assembly by the front end and internal sealing assemblies in an environment containing an inert gas.

6. The dispensing kit according to claim 2, wherein the internal sealing assembly is operable to slide toward the front end sealing assembly during a dispensing operation.

7. The dispensing kit according to claim 1, wherein the dispensing assembly includes a housing having an interior compartment formed therein, wherein the housing is configured to be secured to a portion of the medicament container.

8. The dispensing kit according to claim 7, wherein the front end sealing assembly moves into the interior compartment of the housing upon activation of the dispensing assembly.

9. The dispensing kit according to claim 8, wherein the front end sealing assembly includes at least one projection extending from an end portion of the front end sealing assembly, the at least one projection configured to contact a surface of the interior compartment during a dispensing operation.

10. The dispensing kit according to claim 9, wherein the dispensing assembly further includes a needle for injecting the predetermined dose of medication into the user upon activation of the dispensing assembly, wherein the at least one projection is positioned adjacent an end portion of the needle during a dispensing operation.

11. The dispensing kit according to claim 1, wherein the sealed package includes a plurality of sealed interior compartments, wherein each sealed compartment contains a medicament container having the predetermined dose of medication located therein, a dispensing assembly, an oxygen absorbing material, and an inert gas located therein.

12. The dispensing kit according to claim 11, wherein the sealed package is a high barrier pouch.

13. The dispensing kit according to claim 12, wherein the high barrier pouch is a laminated pouch having more than one layer.

14. The dispensing kit according to claim 13, wherein one of the layers of the laminated pouch contains an aluminum foil layer.

15. The dispensing kit according to claim 13, wherein one of the layers contains the oxygen absorbing component.

16. The dispensing kit according to claim 1, wherein the sealed package is a high barrier pouch.

17. The dispensing kit according to claim 16, wherein the high barrier pouch is a laminated pouch having more than one layer.

18. The dispensing kit according to claim 17, wherein one of the layers of the laminated pouch contains an aluminum foil layer.

19. The dispensing kit according to claim 17, wherein one of the layers contains the oxygen absorbing component.

20. The dispensing kit according to claim 1, wherein the dispensing assembly comprises:

a dispensing element for administering the predetermined dose of medication from the medicament container in response to activation of the dispensing assembly.

21. The dispensing kit according to claim 20, wherein the dispensing element further includes a needle for injecting the predetermined dose of medication into the user upon activation of the dispensing assembly.

22. The dispensing kit according to claim 1, wherein the predetermined dose of medication includes one of dihydroergotamine, epinephrine and an oxygen sensitive medicament.

23. The dispensing kit according to claim 1, wherein a second passageway is formed in the exterior surface of the front end sealing assembly.

24. The dispensing kit according to claim 1, wherein the front end sealing assembly moves from a venting position to a sealing position after the filling operation and from the sealing position to a dispensing position in response to activation of the dispensing assembly, the venting position and the dispensing position being the same position with respect to the medicament container.

25. The dispensing kit according to claim 1, wherein the dispensing assembly contains the gas absorbing component.

26. The dispensing kit according to claim 1, wherein the medicament container contains the gas absorbing component.

27. The dispensing kit according to claim 1, wherein at least a portion of the dispensing assembly is formed from a gas absorbing material.

28. The dispensing kit according to claim 1, further comprising a rigid secondary package, wherein the sealed package is located within an interior of the rigid secondary package.

29. A medicament dispensing kit for administering a predetermined dose of medication, the medicament dispensing kit comprising:

a predetermined dose of medication;

a medicament container containing the predetermined dose of medication and comprising;

a cartridge assembly operative to receive the predetermined dose of medication and having an opening formed therein, and

a movable sealing assembly operative in a first position to seal the opening in the cartridge assembly, the sealing assembly comprising;

an end portion having a plurality of projections extending therefrom, and

a venting assembly operative to vent a gas from an interior of the cartridge assembly when the sealing assembly is in a second position after the predetermined dose of medication has been filled therein and before activation of a dispensing operation;

a dispensing assembly configured to receive the medicament container therein, wherein the dispensing assembly dispenses the predetermined dose of medication upon activation by a user, the activation causing the sealing assembly to move to the second position wherein the plurality of projections contacts an interior surface of the dispensing assembly to form a liquid communication path allowing the predetermined dose of medication to pass through the venting assembly, around the end portion, and through a space created between the projections and the interior surface of the dispensing assembly;

a gas absorbing component; and

a sealed package forming a sealed interior compartment, the sealed interior compartment including the medicament container having the predetermined dose of medication located therein and the dispensing assembly.

30. The dispensing kit according to claim 29 wherein the sealed package is a high barrier pouch.

31. The dispensing kit according to claim 30 wherein the high barrier pouch is a laminated pouch having more than one layer.

32. The dispensing kit according to claim 31 wherein one of the layers of the laminated pouch contains an aluminum foil layer.

33. The dispensing kit according to claim 31 wherein one of the layers contains the gas absorbing component.

34. The dispensing kit according to claim 29 wherein the sealing assembly is formed from one of an oxygen absorbing material, an oxygen barrier material, and an oxygen permeable material.

35. The dispensing kit according to claim 34 wherein the oxygen absorbing material and the oxygen barrier material are rubber.

36. The dispensing kit according to claim 29 further comprising an inert gas located within the sealed interior compartment.

37. The dispensing kit according to claim 29 wherein the predetermined dose of medication includes one of dihydroergotamine, epinephrine, and an oxygen sensitive medicament.

38. The dispensing kit according to claim 29 wherein the gas absorbing component comprises an oxygen absorbing substance.

39. The dispensing kit according to claim 29 wherein the dispensing assembly includes a needle for injecting the predetermined dose of medication into a user upon activation of the dispensing assembly.

40. The dispensing kit according to claim 29 wherein the dispensing assembly contains the gas absorbing component.

41. The dispensing kit according to claim 29 wherein the medicament container contains the gas absorbing component.

42. The dispensing kit according to claim 29 wherein at least a portion of the dispensing assembly is formed from a gas absorbing material.

43. The dispensing kit according to claim 29 further comprising a rigid secondary package, the sealed package located within an interior of the rigid secondary package.

44. The dispensing kit according to claim 29 wherein the sealed package forms a sealed interior compartment flushed with an inert gas to remove oxygen, the sealed interior compartment including the inert gas therein.

45. The dispensing kit according to claim 29 wherein the venting assembly comprises a body portion having a passageway formed in and extending along an exterior surface of the body portion.

46. A medicament dispensing kit for administering a predetermined dose of medication, the medicament dispensing kit comprising:

a predetermined dose of medication;

a medicament container containing the predetermined dose of medication, the container comprising a front end sealing assembly having a storage position relative to the container which seals the dose of medication in the container, the front end sealing assembly comprising a body portion that frictionally engages an inner surface of the container, the body portion having a passageway formed in a portion of an exterior surface of the body portion, the passageway operable to vent gases from the container during a container filling operation and operable to pass the predetermined dose of medication there through from the container during a medication dispensing operation;

a dispensing assembly configured to receive the medicament container therein and to dispense the predetermined dose of medication upon activation by a user; and

a sealed package forming a sealed interior compartment that has the dispensing assembly and the medicament container having the predetermined dose of medication located therein.

47. The dispensing kit according to claim 46, wherein the front end sealing assembly moves from a venting position to a sealing position after the filling operation and from the sealing position to a dispensing position in response to activation of the dispensing assembly.

48. The dispensing kit according to claim 47, wherein the venting position and the dispensing position are the same position with respect to the medicament container.

49. The dispensing kit according to claim 46 wherein the sealed package comprises a laminated pouch having more than one layer.

50. The dispensing kit according to claim 46 wherein one of the layers comprises an aluminum foil layer.

51. The dispensing kit according to claim 49 wherein one of the layers comprises a gas absorbing component.

52. The dispensing kit according to claim 46 further comprising a gas absorbing component.

53. The dispensing kit according to claim 46 wherein the dispensing assembly comprises a gas absorbing component.

54. The dispensing kit according to claim 46 wherein the medicament container comprises a gas absorbing component.

55. The dispensing kit according to claim 46 wherein the sealed package is flushed with an inert gas to remove oxygen from the interior compartment.

56. The dispensing kit according to claim 46, wherein the front end sealing assembly is formed from rubber.

57. The dispensing kit according to claim 46, wherein the predetermined dose of medication includes an oxygen sensitive medicament.

58. The dispensing kit according to claim 46, wherein the dispensing assembly includes a needle for injecting the predetermined dose of medication into the user upon activation of the dispensing assembly.

59. The dispensing kit according to claim 46, wherein the dispensing assembly includes a nasal sprayer for spraying the predetermined dose of medication into the user upon activation of the dispensing assembly.

60. The dispensing kit according to claim 46 wherein the sealed package comprises a high barrier pouch.