Metered dose delivery device for liquid and powder agents

• US 20030015191A1
• Filed: 04/26/2002
• Published: 01/23/2003
• Est. Priority Date: 04/26/2001
• Status: Active Grant

• Current Assignee: New England Pharmaceuticals, Inc. (Sumitomo Pharma America, Inc.)
• Original Assignee: New England Pharmaceuticals, Inc. (Sumitomo Pharma America, Inc.)
• Inventors: Armstrong, John C., Palson, Richard C.J.
• Granted Patent: US 7,025,058 B2
• Time in Patent Office: Days
• US Class Current: 128/200.21
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0081 Locking means
• 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: A61M 2202/064 Powder

Abstract

A delivery device for the delivery of an agent to the mouth, nose or other bodily site of a user. The delivery device includes an aerosol canister that is actuated to expel propellant, which captures and disperses the agent. In a preferred embodiment, the propellant captures and disperses the agent into the mouth or nose of a user, and inhalation by the user directs the agent to the lungs of the user. The delivery device is particularly suitable for the treatment of bronchial asthma, respiratory conditions and for the delivery of systemically absorbed agents.

Claims

46. A device for delivery of an agent into the mouth or nose of a user, wherein the agent is dispersed by actuation of canister which drives propellant through the device, wherein the agent is housed within a container, and wherein a piercing member having at least a hollow tip portion pierces the container, thereby picking up agent, and whereby the hollow portion of the piercing member is sized to pick up a precise dose of agent.

47. A device for delivery of an agent into the mouth or nose of a user, wherein the agent is delivered by actuation of a canister which expels propellant, wherein the agent is housed within a container, wherein a piercing member pierces the container thereby picking up the agent, and wherein the container has a thickness that controls the dose of agent picked up by the piercing member.

48. A device for delivery of an agent into the mouth or nose of a user, wherein the agent is delivered by actuation of a canister which expels propellant and wherein the propellant picks up the agent and delivers it to the mouth or nose of a user.

50. A method for the delivery of inhalable medicinal agents, the method comprising the steps of:

(a) providing a device for delivery of an agent comprising;

a body member having at a first end an aerosol canister housing a propellant and a second end for insertion into the mouth or nose of a user, the aerosol canister being movable downwards within the body member;

a container within the body member, for holding the agent, positioned between the aerosol canister and second end; and

a piercing member between the aerosol canister and the container;

(b) inserting the second end of the body member into the mouth or nose of the user;

(c) carrying agent towards the second end of the body member by passing the piercing member through the container;

(d) actuating the aerosol canister to expel propellant through the body member towards the second end by moving the aerosol canister downwards toward the second end; and

(e) allowing the propellant to disperse the agent into the mouth or nose of a user.

52. A method for the delivery of inhalable medicinal agents, the method comprising the steps of:

(a) providing a device for delivery of an agent comprising;

a body member having at a first end an aerosol canister housing a propellant and a second end for insertion into the mouth or nose of a user, the aerosol canister being movable downwards within the body member; and

a container within the body member, for holding the agent, positioned between the aerosol canister and second end; and

(b) inserting the second end of the body member into the mouth or nose of the user;

(c) actuating the aerosol canister to expel propellant through the body member towards the second end, by moving the aerosol canister downwards toward the second end; and

(d) allowing the propellant to disperse the agent into the mouth or nose of a user.

53. A metered dose inhaler for the delivery of an agent, wherein the agent and a propellant combine at the instant of actuation of the inhaler.

54. A device for delivery of an agent comprising:

a body member having a first end and a second end;

the second end adapted for insertion into the mouth or nose of a user;

an aerosol canister housing a pure propellent positioned at the first end of the body member;

a container housing the agent;

whereby the agent and propellant combine at the instant of actuation of the aerosol canister and whereby the propellant disperses the agent into the mouth or nose of a user.

55. A device for delivery of an agent comprising:

a body member having a first end and a second end;

the second end adapted for insertion into the mouth or nose of a user;

an aerosol canister housing a propellent positioned at the first end of the body member; and

a container housing a pure agent;

whereby the agent and propellant combine at the instant of actuation of the aerosol canister and whereby the propellant disperses the agent into the mouth or nose of a user.

1. A device for delivery of an agent comprising:

a body member having at a first end a canister housing a propellant and a second end adapted for insertion into the mouth or nose of a user; and

a container within the body member, for holding the agent, wherein the container is positioned between the canister and second end;

whereby as the canister is moved towards the container, the canister is actuated to expel the propellant and agent into the mouth or nose of the user.

2. The device of claim 1, further comprising a mechanism for exposing the agent in the container to the propellant, the mechanism positioned between the canister and the container.

3. The device of claim 2, whereby as the canister is moved towards the container, the mechanism passes through the container, thereby carrying the agent towards the second end.

4. The device of claim 3, wherein the mechanism is sized to carry a precise dose of agent to the second end.

5. The device of claim 3, wherein the size of the mechanism controls the dose of agent delivered by the device.

6. The device of claim 2 or 3, wherein the mechanism is a piercing member.

7. The device of claim 6, whereby as the canister is moved towards the container, the piercing member passes through the container, thereby carrying the agent towards the second end.

8. The device of claim 7, wherein at least the tip portion of the piercing member is hollow and the agent is picked up within the hollow portion of the piercing member.

9. The device of claim 8, wherein the inner diameter of the piercing member is sized to pick up a precise dose of agent.

10. The device of claim 8, wherein the size of the inner diameter of the piercing member controls the dose of agent delivered by the device.

11. The device of claim 9, wherein the inner diameter of the piercing member ranges from about 0.005″

to about 0.1″

.

12. The device of claim 9, wherein the inner diameter of the piercing member ranges from about 0.01″

to about 0.08″

.

13. The device of claim 9, wherein the canister is connected to the piercing member such that the propellant is expelled from the canister through the hollow portion of the piercing member, thereby expelling the agent from the piercing member.

14. The device of claim 6, wherein the piercing member is a needle.

15. The device of claim 6, wherein the piercing member is sharpened at the piercing end to about a 30°

to 60°

angle and the rim of the piercing member opposite the apex is blunted.

16. The device of claim 1, wherein the thickness of the container holding the agent controls the dose of agent delivered by the device.

17. The device of claim 6, wherein the container is partially filled with the agent.

18. The device of claim 17, wherein the agent is housed within at least one compartment within the container.

19. The device of claim 18, wherein the agent is housed within a single center compartment within the container.

20. The device of claim 18 or 19, wherein the at least one compartment is cylindrically shaped.

21. The device of claim 17, wherein the at least one compartment has a cross section approximately the same as the cross section of the piercing member to minimize any residue of agent in the container

22. The device of claim 16, wherein the height of the at least one compartment housing the agent controls the dose of agent delivered by the device.

23. The device of claim 18, wherein a plurality of compartments are positioned in a circle within the container.

24. The device of claim 23, further comprising a rotating mechanism for rotating the container such that each of the plurality of compartments may be lined up with the piercing member.

25. The device of claim 24, further comprising a locking mechanism for locking the container into place during rotation, whereby the locking mechanism locks the container in place each time a compartment is lined up with the piercing member.

26. The device of claim 1, wherein a dose ranges from about 5 μ

g to about 30 mg.

27. The device of claim 1, wherein a dose ranges from about 10 μ

g to about 20 mg.

28. The device of claim 1, wherein the agent comprises finely divided particles, the finely divided particles having diameters ranging from about 1 micron to about 50 microns.

29. The device of claim 1, wherein the agent comprises finely divided particles, the finely divided particles having diameters ranging from about 3 microns to about 50 microns.

30. The device of claim 1, wherein the agent is one or more medicinal agent.

31. The device of claim 1, wherein the agent is a liquid.

32. The device of claim 6, further comprising at least one bypass pathway extending from the canister, around the agent in the container and towards to second end, whereby at least a portion of the propellant travels through the at least one bypass pathway and at least a portion of the propellant travels through the container and carries the agent towards the second end.

33. The device of claim 32, wherein the portion of the propellant in the bypass pathway mixes with a portion of the propellant that travels through the container, and thereby assists in delivering the agent to the mouth or nose of a user.

34. The device of claim 32 or 33, further comprising swirl chamber into which the agent from the container and the portion of the propellant that travels through the container are expelled, the swirl chamber being the location where the at least one bypass pathway expels the portion of the propellant traveling through the bypass pathway.

35. The device of claim 1, wherein the propellant is a chlorofluorocarbon or hydrofluoroalkane propellant.

36. The device of claim 35, wherein the propellantis selected from hydrofluoroalkane 134a and hydrofluoroalkane 227.

37. The device of claim 1, wherein the canister further houses an agent in suspension or solution.

38. The device of claim 37, wherein the agent is selected from flavoring agents, surfactants, water, alcohol or other solvents, and medicinal agents.

39. The device of claim 38, wherein the agent is one or more medicinal agent.

40. The device of claim 37, wherein the aerosol canister includes a valve stem through which propellant is expelled, and wherein the valve stem comprises the piercing member.

41. The device of claim 1, further comprising a stop member positioned between the canister and container, whereby the canister contacts the stop member as the canister is moved downwards and is actuated thereby.

42. The device of claim 1, further comprising a fastening mechanism connecting the first end of the body member to the second end of the body member such that the first end is separable from the second end.

43. The device of claim 1, wherein the aerosol canister includes a metering valve.

44. The device of claim 6, wherein the piercing member is a blade or blade-like member.

45. The device of claim 1, wherein the canister is a disposable single-use pressurized aerosol canister.

49. A delivery device kit, comprising one or more of the delivery devices of claim 1 and one or more a containers each holding at least one agent.

51. The method for the delivery of an agent to the mouth or nose of a user comprising using the device of claim 1 to administer the agent, wherein the propellant disperses the agent and the user provides inhalation to direct the agent to the lungs.

57. The device of claim 56, wherein the respirable fraction is at least about 35%.

58. The device of claim 56, wherein the respirable fraction is at least about 40%.

59. The device of claim 56, wherein the respirable fraction is at least about 45%.

60. The device of claim 56, wherein the respirable fraction is at least about 50%.

61. The device of claim 56, wherein the respirable fraction is at least about 55%.

67. The device of claim 56, wherein the respirable fraction is at least about 60%.

63. The device of claim 56, wherein the respirable fraction is at least about 65%.

64. The device of claim 56, wherein the respirable fraction is at least about 70%.

65. The device of claim 56, wherein the respirable fraction is at least about 75%.

66. The device of claim 56, wherein the respirable fraction is at least about 80%.

56. A device for delivery of an agent wherein the device delivers a respirable fraction of agent of at least about 30%.

67-1. The device of claim 56, wherein the respirable fraction is at least about 85%.

68. A device for the systemic delivery of medicinal agents to treat diabetes.

69. A device for the delivery of an agent comprising:

a body member having at a first end an aerosol canister housing a propellant and a second end adapted for insertion into the mouth or nose of a user;

a container within the body member for holding the agent;

whereby the agent and propellant are separate until actuation of the aerosol canister;

whereby actuation of the aerosol canister expels the propellant to capture and disperse the agent out of the second end of the body member; and

whereby the propellant and dispersed agent exit the second end of the body member in a cloud-like formation that remains visible for at least about 3 seconds.

70. A device for the delivery of a plurality of agents comprising:

a body member having at a first end an aerosol canister housing a propellant and a second end adapted for insertion into the mouth or nose of a user;

a container within the body member, for holding the plurality of agents; and

the plurality of agents separated from each other in the container;

whereby the plurality of agents and propellant combine at the instant of actuation of the aerosol canister and whereby the propellant disperses the plurality of agents into the mouth or nose of a user.

71. A device for delivery of an agent comprising:

a body member having at a first end a canister housing a propellant and a second end adapted for insertion into the mouth or nose of a user; and

a container within the body member, for holding the agent, wherein the container is positioned between the canister and second end;

whereby the thickness of the container holding the agent controls the dose of agent delivered by the device.