Nasal drug delivery device

• US 10,507,295 B2
• Filed: 10/28/2016
• Issued: 12/17/2019
• Est. Priority Date: 03/03/2011
• Status: Active Grant

• Current Assignee: Woodward Specialty LLC
• Original Assignee: Impel Neuropharma Inc.
• Inventors: Hoekman, John D., Hite, Michael, Brunelle, Alan, Relethford, Joel, Ho, Rodney J. Y.
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US15/338,097
• Publication Number:
  US 20170043109A1
• Time in Patent Office: 1,145 Days
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A compound delivery device for delivering a plume derived from a propellant and a drug formulation. The drug formulation is in an intranasal dosage form in the form of powder, suspension, dispersion or liquid. The propelled intranasal dosage form is deposited within the olfactory region of the nasal cavity. The drug deposited within the olfactory region is delivered to the brain avoiding the blood-brain-barrier. Hydrofluoroalkane propellant from a pressurized canister is channeled to a diffuser and drug-containing chamber where the intra-nasal dosage form is aerosolized. The aerosolized intra-nasal dosage form passes through a nozzle thus delivering a plume to the olfactory region of a user'"'"'s nasal cavity.

Claims

1. A device for delivery of a compound to an olfactory region of a nasal cavity, the device comprising:

an actuator body comprising a vertical portion and an angled portion, the vertical portion comprising a contoured surface to accommodate a facial component of a user'"'"'s face and configured to house a pressurized propellant container containing propellant and a first portion of a connection channel, the first portion of the connection channel configured to be in communication with the propellant container, the angled portion comprising an additional contoured surface to accommodate an additional component of the user'"'"'s face and configured to house a second portion of the connection channel;

a diffuser in communication with the second portion of the connection channel;

a drug chamber in communication with the diffuser, the drug chamber configured to hold the compound;

a nozzle in communication with the drug chamber, wherein propellant released from the propellant container is configured to travel through the connection channel, contact the diffuser, and propel the compound out the nozzle forming a plume.

2. The device of claim 1, wherein the diffuser is heterogeneously porous or homogenously porous.

3. The device of claim 1, wherein the diffuser is a porous frit.

4. The device of claim 1, wherein the compound is a drug or diagnostic agent.

5. The device of claim 4, wherein the diagnostic agent is an imaging agent.

6. The device of claim 1, further comprising an aiming guide.

7. The device of claim 6, wherein the aiming guide is at least one of:

a nose-aiming guide positioned on the actuator body to accommodate a nose of the user or to aim the nozzle at the olfactory region of the user;

a septum-aiming guide positioned on the actuator body to accommodate a septum of the user; and

a lip aiming guide positioned on the actuator body to accommodate a lip of the user.

8. The device of claim 1, further comprising an insertion port in communication with the drug chamber, the insertion port being configured to receive insertion of the compound from outside the device into the drug chamber.

9. The device of claim 1, wherein the diffuser extends into the compound in the drug chamber.

10. The device of claim 1, wherein the diffuser is configured to convert the propellant from a liquid to a gas.

11. The device of claim 1, wherein the diffuser is configured to act as a one way check valve.

12. The device of claim 1, wherein the diffuser is configured to diffuse a majority or a minority of the propellant.

13. The device of claim 1, further comprising a drug capsule that couples to the actuator body and houses the diffuser, the drug chamber, and the nozzle.

14. The device of claim 13, wherein the drug capsule comprises a tapered end for positioning the drug capsule near a septum of the user, wherein the tapered end is configured to position the drug capsule at a suitable horizontal angle relative to the nasal cavity.

15. The device of claim 13, wherein the drug capsule comprises a visual indicator that indicates to the user a length or an amount of insertion of the drug capsule into the nasal cavity of the user.

16. The device of claim 1, wherein the container comprises a metering valve assembly coupled to a proximal end of the propellant container, the metering valve assembly configured to be in communication with the diffuser.

17. The device of claim 16, wherein the metering valve assembly comprises a valve stem that is configured to protrude from the proximal end of the propellant container.

18. The device of claim 1, wherein the diffuser is disposed across a diameter of the connection channel.

19. The device of claim 1, wherein the drug chamber is positioned in-line with the connection channel.

20. A device for delivering a compound to an olfactory region of a nasal cavity, the device comprising:

an actuator body comprising a vertical portion and an angled portion, the vertical portion comprising a contoured surface to accommodate a facial component of a user'"'"'s face and configured to house a canister containing a propellant, the angled portion comprising an additional contoured surface to accommodate an additional facial component of the user'"'"'s face;

a diffuser configured to be in communication with the canister;

a compound chamber in communication with the diffuser, the compound chamber configured to contain the compound;

a nozzle in communication with the compound chamber, wherein propellant released from the canister is configured to contact the diffuser such that diffused propellant propels the compound out the nozzle forming a plume.

21. The device of claim 20, wherein the diffuser is heterogeneously porous or homogenously porous.

22. The device of claim 20, wherein the diffuser is a porous frit.

23. The device of claim 20, wherein the compound is a drug or diagnostic agent.

24. The device of claim 20, further comprising an aiming guide.

25. The device of claim 20, further comprising an insertion port in communication with the compound chamber, the insertion port being configured to receive insertion of the compound from outside the device into the compound chamber.

26. The device of claim 20, wherein the diffuser extends into the compound in the compound chamber.

27. The device of claim 20, wherein the diffuser is configured to convert the propellant from a liquid to a gas.