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

• US 20030106824A1
• Filed: 11/01/2002
• Published: 06/12/2003
• 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.
• Granted Patent: US 7,708,719 B2
• Time in Patent Office: Days
• US Class Current: 206/439
• 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;

a dispensing assembly adapted 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, wherein the sealed interior compartment contains the medicament container having the predetermined dose of medication located therein, the dispensing assembly and the gas absorbing material.

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

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

a cartridge assembly for receiving the predetermined dose of medication having at least one opening formed therein; and

at least one sealing assembly for sealing the at least one opening in the cartridge assembly.

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

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

6. The dispensing kit according to claim 3, wherein the predetermined dose of medication is sealed within the cartridge assembly by the sealing assembly in an environment containing an inert gas.

7. The dispensing kit according to claim 6, wherein each of the at least one sealing assembly is formed from one of an oxygen absorbing material, an oxygen barrier material, and an oxygen permeable material.

8. The dispensing kit according to claim 7, wherein the oxygen absorbing material and the oxygen barrier material are rubber.

9. The dispensing kit according to claim 3, wherein one of at least one sealing assembly includes a venting assembly for venting the inert gas from an interior of the cartridge assembly after the predetermined dose of medication has been located therein.

10. The dispensing kit according to claim 3, wherein one of at least one sealing assembly includes a flexible diaphragm.

11. The dispensing kit according to claim 3, wherein the medicament container further comprising:

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

12. The dispensing kit according to claim 11, wherein one of the at least one sealing assembly moves from a sealing position to a dispensing position in response to activation of the dispensing assembly.

13. The dispensing kit according to claim 12, wherein the dispensing element includes a housing having an interior compartment formed therein, wherein the housing is adapted to be secured to a portion of the cartridge assembly.

14. The dispensing kit according to claim 13, wherein the one sealing assembly moves into the interior compartment of the housing upon activation of the dispensing assembly.

15. The dispensing kit according to claim 14, wherein the one sealing assembly includes at least one projection extending from an end portion of the one sealing assembly, wherein the at least one projection is adapted to contact a surface of the interior compartment during a dispensing operation.

16. The dispensing kit according to claim 15, wherein the dispensing element 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.

17. The dispensing kit according to claim 11, wherein the dispensing element further includes a needle for injecting the predetermined dose of medication into the user upon activation of the dispensing assembly.

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

19. The dispensing kit according to claim 18, wherein the high barrier pouch is a laminated pouch having more than one layer.

20. The dispensing kit according to claim 19, wherein one of the layers of the laminated pouch contains an aluminum foil layer.

21. The dispensing kit according to claim 20, wherein one of the layers contains the oxygen absorbing component.

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

23. 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.

24. The dispensing kit according to claim 23, wherein the sealed package is a high barrier pouch.

25. The dispensing kit according to claim 24, wherein the high barrier pouch is a laminated pouch having more than one layer.

26. The dispensing kit according to claim 25, wherein one the layers of the laminated pouch contains an aluminum foil layer.

27. The dispensing kit according to claim 25, wherein one of the layers contains the oxygen absorbing component.

28. The dispensing kit according to claim 1, further comprising an inert gas located within the sealed interior compartment.

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

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

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

32. 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.

33. A method of packaging a predetermined dose of medication, the method comprising the steps of:

providing a predetermined dose of medication;

filling a medicament container with the predetermined dose of medication in an environment containing an inert gas;

sealing the medicament container in the environment containing the inert gas;

locating the medicament container in a dispensing assembly;

locating the dispensing assembly in a package;

providing a gas absorbing material in one of the dispensing assembly, the medicament container and the package; and

sealing the package.

34. The method according to claim 33, wherein the step of filling the medicament container comprises:

purging an interior compartment of the medicament container using an inert gas; and

filling the interior compartment with the predetermined dose of the medication.

35. The method according to claim 34, wherein the step of sealing the medicament container comprises:

placing a stopper assembly in an opening in the medicament container in a venting position;

withdrawing at least a portion of the inert gas from the interior compartment; and

moving the stopper assembly to a sealing position.

36. The method according to claim 35, wherein the step of withdrawing the inert gas includes applying a vacuum to the medicament container to withdraw the inert gas from the interior of the medicament container.

37. The method according to claim 36, wherein the step of locating the dispensing assembly in the package includes flushing the interior of the package with an inert gas during insertion of the dispensing assembly.

38. A medicament container for storing a predetermined dose of medication comprising:

a cartridge assembly having an interior compartment for receiving the predetermined dose of medication therein, wherein the cartridge assembly includes at least one opening; and

a sealing assembly located within one of the at least one opening, wherein the sealing assembly includes a venting assembly for venting the interior compartment of the cartridge assembly at a predetermined time.

39. The medicament container according to claim 38, further comprising:

a dispensing element for administering the predetermined dose of medication from the cartridge assembly.

40. The medicament container according to claim 39, wherein the sealing assembly moves from a sealing position to a dispensing position during a medication dispensing procedure.

41. The medicament container according to claim 40, wherein the dispensing element includes a housing having an interior compartment formed therein, wherein the housing is adapted to be secured to a neck portion of the cartridge assembly adjacent the sealing assembly.

42. The medicament container according to claim 41, wherein the sealing assembly moves into the interior compartment of the housing during the dispensing operation.

43. The medicament container according to claim 42, wherein the venting assembly permits the passage of medication from the cartridge assembly to the housing during the dispensing operation.

44. The medicament container according to claim 43, wherein the sealing assembly includes at least one projection extending from an end portion of the sealing assembly, wherein the at least one projection is adapted to contact a surface of the interior compartment during the dispensing operation.

45. A medicament dispenser assembly comprising:

a predetermined dose of medication;

a medicament container containing the predetermined dose of medication;

a dispensing assembly for receiving the medicament container therein, wherein the dispensing assembly dispenses the predetermined dose of medication upon activation by a user; and

a gas absorbing component in gaseous communication with the medicament container for absorbing gas contained within the medicament container and the dispensing assembly.

46. The medicament dispenser assembly according to claim 45, wherein the dispensing assembly is an auto-injector assembly.

47. The medicament dispenser assembly according to claim 45, wherein the gas absorbing component is located within the dispensing assembly.

48. The medicament dispenser assembly according to claim 45, wherein the dispensing assembly is formed from a gas absorbing component.

49. The medicament dispensing assembly according to claim 48, wherein the gas absorbing component is located within a housing surrounding the dispensing assembly.

50. A method of administering a predetermined dose of medication comprising:

providing a predetermined dose of medication in medicament container;

shielding the predetermined dose of medication from exposure to an undesired gas; and

administering the dose of medication to a patient using an auto-injector assembly.

51. The method of administering a predetermined dose of medication according to claim 50, wherein the shielding of the predetermined dose of medication from exposure to undesired gas includes providing a gas absorbing material in communication with one of the medicament container, the auto-injector assembly and a sealed package containing the auto-injector assembly.

52. The method of administering a predetermined dose of medication according to claim 50, wherein the shielding the predetermined dose of medication from exposure to the undesired gas includes providing a gas absorbing material in communication with the auto-injector assembly within a sealed package containing the auto-injector assembly.

53. The method according to claim 52, further comprising removing the auto-injector from the sealed package prior to administering the dose of medication.

54. An autoinjector drug delivery assembly:

a sealed compartment;

a vial containing a charge of medicament stored within said sealed compartment;

a plunger rearwardly confining said charge of medicament within said vial;

a releasable spring assembly that is releasable to force said plunger through said vial and displace said medicament from said vial;

a needle constructed and arranged to dispense said medicament from said vial as said medicament is displaced from said vial; and

a gas absorbing material disposed within said sealed compartment.

55. The drug delivery package according to claim 54, wherein said sealed compartment is a housing of said autoinjector.

56. The drug delivery package according to claim 55, wherein said housing is under vacuum.

57. The drug delivery package according to claim 54, wherein said sealed compartment is an outer package, further comprising a housing, wherein said autoinjector disposed within said housing.

58. The drug delivery package according to claim 57, wherein said outer package is under vacuum.

59. The drug delivery package according to claim 57, further comprising a secondary rigid package, wherein the outer package is located within the secondary rigid package.

60. A administering a medicament, comprising:

providing a charge of medicament within a vial disposed in a sealed compartment, a plunger rearwardly confining said charge of medicament within said vial, a releasable spring assembly that is releasable to force said plunger through said vial and displace said medicament from said vial, a needle constructed and arranged to dispense said medicament from said vial as said medicament is displaced from said vial; and

providing a gas absorbing material in gaseous communication with said medicament and disposed within said sealed compartment.