Nozzles for Nasal Drug Delivery

• US 20140083424A1
• Filed: 11/08/2013
• Published: 03/27/2014
• Est. Priority Date: 05/09/2011
• Status: Active Grant

• Current Assignee: Woodward Specialty LLC
• Original Assignee: Impel Neuropharma Inc.
• Inventors: Hoekman, John D., Hite, Michael, Brunelle, Alan, Relethford, Joel
• Granted Patent: US 9,919,117 B2
• Time in Patent Office: Days
• US Class Current: 128/203.22
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/127 by Venturi effect, i.e. entrainment mixers
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 2210/1475 Vagina
• CPC Class Codes: B05B 1/14 with multiple outlet openings B05B1/02, B05B1/26 take precedence; with strainers in or outside the outlet opening
• CPC Class Codes: B05B 7/08 with separate outlet orifices, e.g. to form parallel jets , i.e. the axis of the jets being parallel, to form intersecting jets , i.e. the axis of the jets converging but not necessarily intersecting at a point

Abstract

A nozzle for use in delivering a mixture of aerosol propellant and drug formulation. The nozzle includes a drug product inlet configured to receive a mixture of aerosolized propellant and an intranasal dosage form. The inlet is disposed at the proximal end. A nozzle body is secured to the drug product inlet. Two or more channels are disposed within the body. Two or more orifice apertures are disposed at the distal end of the nozzle.

Claims

1. A nozzle comprising:

a drug product inlet configured to receive a mixture of a propellant and an intranasal dosage form, the drug product inlet disposed at a proximal end of the nozzle,

a nozzle body defining at least two channels, the channels having a proximal end and a distal end, the nozzle body defining a longitudinal axis, and,

an outlet orifice disposed at the distal end of each channel,

the outlet orifice disposed at the end of each channel arranged so that a narrow plume exits the nozzle during a delivery time course, wherein an angle of the plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree, or about 0 degree.

2. The nozzle of claim 1 wherein the channels are disposed parallel to the longitudinal axis.

3. The nozzle of claim 1 wherein the channels are disposed at an angle with respect to the longitudinal axis.

4. The nozzle of claim 1 further comprising at least five channels.

5. The nozzle of claim 1 wherein the channels are circular or tubular in shape.

6. The nozzle of claim 1 wherein the channels are conical in shape.

7. The nozzle of claim 1 further comprising four outlet orifices wherein the outlet orifices are circular and arranged in a square.

8. The nozzle of claim 1 further comprising five outlet orifices wherein the outlet orifices are circular in shape and arranged in a pentagon.

9. The nozzle of claim 1 further comprising six outlet orifices wherein the outlet orifices are circular in shape and arranged in a hexagon.

10. The nozzle of claim 1 further comprising six outlet orifices wherein five of the outlet orifices are configured in a pentagon and one outlet orifice is configured at the center of the pentagon.

11. The nozzle of claim 1 further comprising four outlet orifices, the outlet orifices arranged in a substantially straight line.

12. The nozzle of claim 1 further comprising four outlet orifices wherein the outlet orifices are rectangular in shape and radiate out from the longitudinal axis of the nozzle.

13. The nozzle of claim 1 further comprising five outlet orifices wherein the outlet orifices are star shaped and arranged in a pentagon.

14. The nozzle of claim 1, wherein the channels are a plastic or a metal, the nozzle body is a plastic or a metal, and a void is disposed between the channels and the nozzle body.

26. The nozzle of claim 1 wherein the delivery time course is measured over the span of 4 cm from the outlet orifice of the nozzle.

27. The nozzle of claim 26 wherein the delivery time course is measured using high speed blotter recording.

15. A nozzle for delivering a compound to an upper olfactory region of a user comprising:

a nozzle body having a central axis,

a plurality of channels housed within the nozzle body, the channel having a proximal and a distal end,

an inlet disposed at the proximal end of the channel, and

an outlet orifice disposed at the distal end of the channel, the outlet orifice arranged parallel to the central axis of the nozzle.

16. The nozzle of claim 15 wherein a line drawn thru a point on the outlet orifice is an equal distance to the central axis of the nozzle.

17. The nozzle of claim 15 wherein the outlet orifices are arranged so that a narrow plume exits the nozzle.

18. The nozzle of claim 17, wherein an angle of the plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree, or about zero degree.

19. The nozzle of claim 18 wherein the angle of the plume is 5 degrees.

20. The nozzle of claim 15 wherein an impact force delivered by the nozzle is decreased.

21. The nozzle of claim 15 wherein a delivery time for the compound is decreased.

22. A nozzle for delivering a compound to an upper olfactory region of a user comprising:

a nozzle body,

a compound channel housed within the nozzle body, the compound channel having a proximal end and a distal end, the proximal end capable of receiving a compound, the distal end of the compound channel having an outlet orifice, and

a propellant channel, the propellant channel having a proximal end and a distal end, the proximal end capable of receiving a propellant, the distal end of the propellant channel having an outlet orifice, the compound channel being centered within the propellant channel,

wherein the compound and the propellant are capable of being emitted from the respective outlet orifices.

23. The nozzle of claim 22 further comprising at least a second compound channel, wherein the nozzle is capable of delivering more than one compound at a time.

24. The nozzle of claim 22 wherein the compound is a liquid, a powder, a gas, or combinations thereof.

25. The nozzle of claim 22 further comprising a check shut off valve wherein the check shut off valve prevents propellant from flowing through the compound chamber once the compound is released.

28. A nozzle comprising:

a drug product inlet configured to receive a mixture of a propellant and an intranasal dosage form, the drug product inlet disposed at a proximal end of the nozzle,

a nozzle body defining at least two channels, the channels having a proximal end and a distal end, the nozzle body defining a longitudinal axis, and

an outlet orifice disposed at the distal end of each channel so that a narrow plume exits the nozzle during a delivery time course measured 4 cm from the outlet orifice of the nozzle, wherein an angle of the plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree, or about 0 degree observed using high speed blotter recording.

29. The nozzle of claim 28 wherein the channels are disposed parallel to the longitudinal axis.

30. The nozzle of claim 28 wherein the channels are disposed at an angle with respect to the longitudinal axis.

31. The nozzle of claim 28 further comprising at least five channels.

32. The nozzle of claim 28 wherein the channels are circular or tubular in shape.

33. The nozzle of claim 28 wherein the channels are conical in shape.

34. The nozzle of claim 28 further comprising four outlet orifices wherein the outlet orifices are circular and arranged in a square.

35. The nozzle of claim 28 further comprising five outlet orifices wherein the outlet orifices are circular in shape and arranged in a pentagon.

36. The nozzle of claim 28 further comprising six outlet orifices wherein the outlet orifices are circular in shape and arranged in a hexagon.

37. The nozzle of claim 28 further comprising six outlet orifices wherein five of the outlet orifices are arranged in a pentagon and one outlet orifice is arranged at the center of the pentagon.

38. The nozzle of claim 28 further comprising four outlet orifices, the outlet orifices arranged in a substantially straight line.

39. The nozzle of claim 28 further comprising four outlet orifices wherein the outlet orifices are rectangular in shape and radiate out from the longitudinal axis of the nozzle.

40. The nozzle of claim 28 further comprising five outlet orifices wherein the outlet orifices are star shaped and arranged in a pentagon.

41. The nozzle of claim 28 wherein the channels are a plastic or a metal, the nozzle body is a plastic or a metal, and a void is disposed between the channels and the nozzle body.