Multiple dose condensation aerosol devices and methods of forming condensation aerosols

• US 7,540,286 B2
• Filed: 06/03/2004
• Issued: 06/02/2009
• Est. Priority Date: 06/03/2004
• Status: Active Grant

• Current Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Original Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Inventors: Shen, William W., Herbette, Mathieu, Kelly, Andrew J. G., Tom, Curtis, Myers, Daniel J., Wensley, Martin J., Virgili, Justin M., Timmons, Ryan D., Cross, Steven D.
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US10/861,554
• Publication Number:
  US 20050268911A1
• Time in Patent Office: 1,825 Days
• Field of Search: 128/200.24, 128/203.15, 128/203.24, 128/204.17, 128/203.26, 128/203.27, 128/202.21, 128/203.12
• US Class Current: 128/204.17
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 11/041 using heaters
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: H05B 1/0244 Heating of fluids H05B1/0247 takes precedence
• CPC Class Codes: H05B 2203/021 Heaters specially adapted for heating liquids

Abstract

Devices and methods of entraining a substance within an airflow are disclosed. Condensation aerosol delivery devices and methods of consistently producing multiple doses of a substance, such as a drug, having high purity, high yield, characterized by a particle size distribution appropriate for pulmonary delivery, and which can be administered to a user in a single dose are also disclosed.

Claims

1. A device for entraining a substance within an airflow comprising:

an airway comprising an inlet, and an outlet;

a plurality of supports disposed within the airway;

a substance disposed on at least one of the plurality supports;

a mechanism configured to release the substance from each of the at least one of the plurality of supports; and

airflow routing means for routing an airflow within the airway to entrain the substance in the airflow when released from a support and for inhibiting deposits of the substance on any other support.

13. The device of claim 1 wherein the airflow routing means comprises a first airflow between the inlet and the outlet and a second airflow transverse the first airflow directed from the plurality of supports to separate the substance from the plurality of supports and to entrain the substance in the first airflow.

14. The device of claim 13 wherein the plurality of supports are disposed in series between the airway inlet and the airway outlet.

15. The device of claim 1 wherein the plurality of supports each comprise a resistive heating element and the mechanism configured to release the substance from each of the plurality of supports comprises an electric current through the resistive heating elements.

16. The device of claim 15 further comprising a power supply and a switch operatively disposed between the power supply and the plurality of resistive heating elements for selectively providing an electric current to a select heating element.

17. The device of claim 15 wherein each resistive heating element comprises a metal foil.

18. The device of claim 17 wherein the metal foil is arched.

19. The device of claim 18 wherein resistive heating elements are disposed in series between the airway inlet and the airway outlet.

2. A device for producing a condensation aerosol in an airflow comprising:

an airway comprising an inlet, and an outlet;

a plurality of supports disposed within the airway;

a substance disposed on at least one support of the plurality of supports;

a mechanism configured to vaporize the substance from each support of the plurality of supports on which the substance is disposed; and

airflow routing means routing an airflow within the airway to forms condensation aerosol particles from the vaporized substance that is entrained in the airflow when vaporized and for inhibiting deposits of aerosol particles on any other support.

3. The device of claim 2, wherein each support of the plurality of supports comprises an electrically resistive heating element.

4. The device of claim 2, wherein is the airflow routing means comprises a first airflow between the inlet and the outlet and a second airflow directed through a plurality of holes toward the supports and the first airflow, wherein as the substance forms condensation aerosol particles the particles are entrained in the first airflow and directed away from the plurality of supports by the second airflow.

5. The device of claim 3, wherein each support comprises a metal foil.

20. The device of claim 5 wherein the metal foil is arched.

21. The device of claim 3 wherein the mechanism configured to vaporize the substance from each support comprises an electric current through the resistive heating element.

22. The device of claim 21 further comprising a power supply and a switch operatively disposed between the power supply and the plurality of resistive heating elements for selectively providing an electric current to a select heating element.

23. The device of claim 22 wherein the plurality of supports are disposed in series between the airway inlet and the airway outlet.

33. The device of claim 5, wherein the metal foil is stainless steel.

34. The device of claim 5, wherein the thickness of the metal foil is less than 0.01 inches.

35. The device of claim 5, wherein the thickness of the metal foil is less than 0.001 inches.

36. The device of claim 5, wherein the thickness of the metal foil is less than 0.0005 inches.

37. The device of claim 5, wherein the surface area of the metal foil ranges from 0.01 cm2 to 50 cm2.

38. The device of claim 5, wherein the metal foil comprises a metal layer plated on the metal foil.

39. The device of claim 38, wherein the metal layer is chosen from gold, silver, nickel, and copper.

40. The device of claim 38, wherein the metal layer is gold.

41. The device of claim 38, wherein the thickness of the metal layer ranges from 0.001 μ

m to 3 μ

m.

42. The device of claim 20, wherein the height of the arch ranges from 0.5 mm to 2 mm.

43. The device of claim 5, wherein an impedance of the heating element is closely matched to an impedance of a power source for heating the heating element.

44. The device of claim 43, wherein the difference between the impedance of the heating element and the impedance of the power source is less than 50% of the impedance of the power source.

45. The device of claim 43, wherein the difference between the impedance of the heating element and the impedance of the power source is less than 10% of the impedance of the power source.

46. The device of claim 43, wherein the difference between the impedance of the heating element and the impedance of the power source is less than 2% of the impedance of the power source.

47. The device of claim 5, wherein the ratio of the surface area of the heating element, to the thermal mass of the heating element is greater than 10 cm²/J/°

C.

48. The device of claim 5, wherein the ratio of the surface area of the heating element, to the thermal mass of the heating element is greater than 100 cm²/J/°

C.

49. The device of claim 5, wherein the ratio of the surface area of the heating element, to the thermal mass of the heating element is greater than 500 cm²/J/°

C.

50. The device of claim 5, wherein the heating element can reach a temperature of at least 250°

C. in less than 500 msec.

51. The device of claim 5, wherein the heating element can reach a temperature of at least 250°

C. in less than 250 msec.

52. The device of claim 5, wherein the heating element can reach a temperature of at least 250°

C. in less than 100 msec.

53. The device of claim 5, wherein the amount of energy to vaporize one milligram of a substance disposed on the heating element is less than 250 joules.

54. The device of claim 5, wherein the amount of energy to vaporize one milligram of a substance disposed on the heating element is less than 50 joules.

55. The device of claim 5, wherein the amount of energy to vaporize one milligram of a substance disposed on the heating element is less than 10 joules.

6. A device for delivering a condensation aerosol comprising a substance to a subject comprising:

a housing;

an airway contained within the housing comprising an inlet, and an outlet;

a mouthpiece coupled to the outlet;

at least one support disposed within the airway;

the substance disposed on the at least one support;

a mechanism configured to vaporize the substance;

a power source for powering the mechanism configured to vaporize the substance;

an actuation mechanism configured to transfer energy from the power source to the mechanism configured to vaporize the substance; and

airflow routing means for routing an airflow within the airway to form a condensation aerosol from the vaporized substance and to substantially prevent the condensation aerosol from being deposited within the airway.

7. The device of claim 6, further comprising an air bypass hole coupled to the outlet.

8. A device for delivering a condensation aerosol comprising a substance to a subject comprising:

a dispensing unit comprising;

a first housing comprising a receptacle for a separable cartridge;

a controller for controlling vaporization of the substance; and

a power source; and

a separable cartridge comprising;

a second housing;

an airway contained within the housing having an inlet, and an outlet;

a mouthpiece coupled to the outlet;

a plurality of electrically resistive heating elements disposed within the airway;

the substance disposed on at least one of the heating elements; and

an actuation mechanism configured to transfer energy from the power source to each of the plurality of heating elements;

wherein an airflow from the inlet to the outlet of the airway causes the substance to vaporize and condense in the airflow to form a condensation aerosol.

9. The device of claim 8, further comprising an air bypass hole coupled to the outlet of the second housing.

10. A method of entraining a substance within an airflow comprising:

providing an airway comprising an inlet and an outlet;

providing a plurality of supports disposed within the airway, wherein the substance is disposed on at least one support of the plurality of supports;

releasing the substance from at least one the support into the airflow; and

routing an airflow within the airway to entrain the substance in the airflow when released from the support and to inhibit deposits of the substance on any other support.

11. The method of claim 10 wherein a first portion of the airflow passes through the airway from the inlet to the outlet and a second portion of the airflow passes through a plurality of holes and is directed transverse the first portion of the airflow toward the at least one support on which the substance is disposed to entrain the substance in the first portion of the airflow.

24. The method of claim 10 wherein the substance is disposed on more than one support of the plurality of supports and selectively releasing the substance from a select one of the more than one supports.

25. The method of claim 24 wherein each support comprises a resistive heating element and the releasing step comprises providing an electric current to the select one of the more than one supports.

26. The method of claim 25 wherein each resistive heating element comprises a metal foil.

27. The method of claim 26 wherein the metal foil is arched.

12. A method of producing a condensation aerosol in an airflow comprising:

providing an airway comprising an inlet and an outlet;

providing a plurality of supports disposed within the airway, wherein the substance is disposed on at least one support of the plurality of supports;

vaporizing the substance from the at least one support into the airflow; and

routing an airflow from the inlet to the outlet such that the substance forms a condensation aerosol when vaporized and the condensation aerosol is entrained in the airflow and deposits of the condensation aerosol on any other support is substantially prevented.

28. The method of claim 12 wherein the routing step comprises routing a first airflow portion through the airway from the inlet to the outlet and routing a second airflow portion transverse the first airflow portion directed from the plurality of supports to separate the condensation aerosol from the plurality of supports and to entrain the aerosol in the first airflow portion.

29. The method of claim 28 wherein the substance is disposed on more than one support of the plurality of supports and selectively vaporizing the substance from a select one of the more than one supports.

30. The method of claim 29 wherein each support comprises a resistive heating element and the vaporizing step comprises providing an electric current to the select one of the more than one supports.

31. The method of claim 30 wherein each resistive heating element comprises a metal foil.

32. The method of claim 31 wherein the metal foil is arched.