Inhalation device for producing a drug aerosol

• US 7,913,688 B2
• Filed: 05/20/2003
• Issued: 03/29/2011
• Est. Priority Date: 11/27/2002
• Status: Active Grant

• Current Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Original Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Inventors: Tom, Curtis, Hale, Ron L., Lloyd, Peter M., Hodges, Craig C., Quintana, Reynaldo J., Cross, Stephen, Rabinowitz, Joshua D., Myers, Daniel J., Wensley, Martin J.
• Primary Examiner(s): Yu; Justine R
• Assistant Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US10/442,385
• Publication Number:
  US 20040099266A1
• Time in Patent Office: 2,870 Days
• Field of Search: 128/202.21, 128/203.26, 128/203.27, 128/204.17, 128/200.14, 128/200.22, 128/203.12, 128/203.24
• US Class Current: 128/203.26
• 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 11/047 by exothermic chemical reaction
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04

Abstract

A device for delivering a drug by inhalation is disclosed. The device includes a body defining an interior flow-through chamber having upstream and downstream chamber openings, and a drug supply unit contained within the chamber for producing, upon actuation, a heated drug vapor in a condensation region of the chamber. Gas drawn through the chamber region at a selected gas-flow rate is effective to form drug condensation particles from the drug vapor having a selected MMAD between 0.02 and 0.1 MMAD or between 1 and 3.5 μm. A gas-flow control valve disposed upstream of the unit functions to limit gas-flow rate through the condensation region to the selected gas-flow rate. An actuation switch in the device activates the drug-supply unit, such that the drug-supply unit can be controlled to produce vapor when the gas-flow rate through the chamber is at the selected flow rate.

Claims

1. A device for delivering a drug by inhalation, comprising:

a) a chamber having upstream and downstream openings;

b) a drug supply unit that produces a drug vapor in a region of said chamber between said upstream and downstream openings;

c) a gas-flow control valve upstream of said region that limits gas flow from a user'"'"'s breath intake through said region to a selected flow rate or flow rate range, effective to condense said drug vapor to form an aerosol;

d) a bypass orifice communicating with said chamber at a point of communication, said bypass orifice being configured to allow bypass gas to enter said chamber under conditions of inhalation actuated selected pressure differential across said bypass orifice, the point of communication preventing the bypass gas from significantly varying the selected flow rate or flow rate range through said region; and

e) an actuation switch for causing said drug supply unit to produce said drug vapor.

2. The device of claim 1, wherein said drug supply unit is contained within said chamber.

3. The device of claim 1, wherein said drug supply unit comprises a heat source and a drug coated substrate.

4. The device of claim 1, wherein drug vapor production is initiated when said selected flow rate or flow rate range is reached.

5. The device of claim 1, wherein drug vapor production is initiated after said selected flow rate or flow rate range is reached.

6. The device of claim 1, wherein said gas-flow control valve comprises an active gas-control element.

7. The device of claim 1, wherein said gas-flow control valve is an orifice.

8. The device of claim 1, wherein said actuation switch comprises a thermistor that is responsive to heat-dissipative effects of gas flow through said chamber.

9. The device of claim 1, wherein said point of communication is downstream of said region.

10. The device of claim 1, further comprising a bypass channel in fluid communication with said bypass orifice.

11. The device of claim 1, further comprising a gas flow sensor.

12. The device of claim 1, further comprising an active gas-control element operatively associated with the bypass orifice.

13. The device of claim 1, further comprising a valve operatively associated with the bypass orifice.

14. The device of claim 1, wherein said device comprises a plurality of bypass orifices.

15. The device of claim 1, further comprising the downstream opening being configured for a user to draw air through the chamber by mouth, the bypass orifice being configured to offset a decrease in airflow produced by the gas control valve as a user draws air into the chamber.

16. The device of claim 1 wherein said device is configured to be handheld.

17. A device for delivering a drug by inhalation, comprising:

a) a chamber having upstream and downstream ends;

b) a drug supply unit that produces drug vapor in a region of said chamber between said upstream and downstream ends;

c) an upstream orifice communicating with said chamber upstream of said region that limits gas flow from a user'"'"'s breath intake through said region to a selected flow rate or flow rate range, effective to condense said drug vapor to form an aerosol;

d) a bypass orifice communicating with said chamber downstream of said region that allows gas to enter said chamber under conditions of inhalation actuated selected pressure differential across said bypass orifice; and

e) an actuation switch for causing said drug supply unit to produce drug vapor.

18. The device of claim 17, wherein said drug supply unit is contained within said chamber.

19. The device of claim 17, wherein said drug supply unit further comprises a heat source and a drug coated substrate.

20. The device of claim 17, wherein drug vapor production is initiated when said selected flow rate or flow rate range is reached.

21. The device of claim 17, wherein drug vapor production is initiated after said selected flow rate or flow rate range is reached.

22. The device of claim 17, wherein said actuation switch comprises a thermistor that is responsive to heat-dissipative effects of gas flow through said chamber.

23. The device of claim 17, further comprising a bypass channel communicating with said bypass orifice.

24. The device of claim 17, further comprising a gas flow sensor.

25. The device of claim 17, wherein said device comprises a plurality of bypass orifices.

26. A device for delivering a drug by inhalation, comprising:

a) a chamber having upstream and downstream openings;

b) a drug supply unit that produces a drug vapor in communication with a condensation region of said chamber between said upstream and downstream openings;

c) a gas-flow control valve upstream of said drug supply unit that allows gas from a user'"'"'s breath intake to enter said condensation region at a selected flow rate or flow rate range to produce a condensation aerosol of a select particulate size range;

d) a bypass orifice communicating with said chamber downstream of said gas-flow control valve at a location that allows gas to enter said chamber under conditions of inhalation actuated selected pressure differential across said bypass orifice without significantly varying the selected flow rate; and

e) an actuation switch for causing said drug supply unit to produce said drug vapor.

27. The device of claim 26, wherein said drug supply unit is contained within said chamber.

28. The device of claim 26, wherein said drug supply unit comprises a heat source and a drug coated substrate.

29. The device of claim 26, wherein drug vapor production is initiated when gas flow through said region reaches the selected flow rate or flow rate range.

30. The device of claim 26, wherein drug vapor production is initiated after gas flow through said region reaches the selected flow rate or flow rate range.

31. The device of claim 26, wherein said gas-flow control valve comprises an active gas-control element.

32. The device of claim 26, wherein said gas-flow control valve is an orifice.

33. The device of claim 26, wherein said actuation switch comprises a thermistor that is responsive to heat-dissipative effects of gas flow through said chamber.

34. The device of claim 26, wherein said bypass orifice communicates with said chamber downstream of said condensation region.

35. The device of claim 26, further comprising a bypass channel communicating with said bypass orifice.

36. The device of claim 26, further comprising a gas flow sensor.

37. The device of claim 26, further comprising an active gas-control element operatively associated with said bypass orifice.

38. The device of claim 26, further comprising a bypass valve operatively associated with the bypass orifice.

39. The device of claim 26, wherein said device comprises a plurality of bypass orifices.

40. The device of claim 26, further comprising the downstream opening being configured for a user to draw air through the chamber by mouth, the bypass orifice being configured to offset a decrease in airflow produced by the gas control valve as a user draws air into the chamber.

41. A device for delivering a drug by inhalation, comprising:

a) a chamber having upstream and downstream ends;

b) a drug supply unit that produces drug vapor in communication with a condensation region of said chamber between said upstream and downstream ends;

c) an upstream orifice communicating with said chamber upstream of said condensation region that allows gas from a user'"'"'s breath intake to enter said condensation region at a selected flow rate or flow rate range to produce a condensation aerosol of a select particle size range;

(d) a bypass orifice communicating with said chamber downstream of said upstream orifice at a location that allows gas to enter said chamber under conditions of inhalation actuated selected gas pressure differential across said bypass orifice without significantly varying the selected flow rate; and

d) an actuation switch for causing said drug supply unit to produce drug vapor.

42. The device of claim 41, wherein said drug supply unit is contained within said chamber.

43. The device of claim 41, wherein said drug supply unit further comprises a heat source and a drug coated substrate.

44. The device of claim 41, wherein drug vapor production is initiated when gas flow through said region reaches a selected flow rate or flow rate range, effective to condense said drug vapor to form an aerosol.

45. The device of claim 41, wherein drug vapor production is initiated after gas flow through said region reaches the selected flow rate or flow rate range.

46. The device of claim 41, wherein said actuation switch comprises a thermistor that is responsive to heat-dissipative effects of gas flow through said chamber.

47. The device of claim 41, wherein said bypass orifice communicates with said chamber downstream of said condensation region.

48. The device of claim 41, further comprising a bypass channel communicating with said bypass orifice.

49. The device of claim 41, further comprising a gas flow sensor.

50. The device of claim 41, wherein said device comprises a plurality of bypass orifices.

51. The device of claim 41, further comprising a bypass valve operatively associated with the bypass orifice.