Nozzles for nasal drug delivery

• US 9,919,117 B2
• Filed: 11/08/2013
• Issued: 03/20/2018
• 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
• Primary Examiner(s): Vasat, Peter S
• Assistant Examiner(s): Luarca, Margaret
• Application Number:
  US14/075,126
• Publication Number:
  US 20140083424A1
• Time in Patent Office: 1,593 Days
• Field of Search: 12820322, 12820014, 12820023
• 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 for delivering an intranasal dosage form comprising:

a distal and a proximal end of the nozzle,

a drug product inlet in fluid connection with the proximal end of the nozzle and configured to receive a mixture of a propellant and the intranasal dosage form,

a nozzle body defining five channels, each of the five channels having a proximal end and a distal end, the nozzle body defining a longitudinal axis,

a circular outlet orifice disposed at the distal end of each of the five channels forming five outlet orifices arranged in a pentagon, and

a container containing a propellant in fluid communication with the drug product inlet, the propellant configured to propel the intranasal dosage form from the drug product inlet through the channels and out the outlet orifices,

each of the five channels configured to generate a stream of intranasal dosage form during a delivery time course which streams form a narrow plume once exited the outlet orifices, wherein an angle of the narrow 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 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.

4. The nozzle of claim 1, wherein the angle of the narrow plume is about 5 degrees.

5. The nozzle of claim 1 wherein an impact force delivered by the nozzle is decreased.

6. The nozzle of claim 1, wherein a delivery time for the intranasal dosage form is decreased.

7. The nozzle of claim 1 wherein the delivery time course is measured over a span of 4 cm from the outlet orifices.

8. The nozzle of claim 7 wherein the delivery time course is measured using high speed blotter recording.

9. The nozzle of claim 1, wherein the

narrow plume once exited the outlet orifices during the delivery time course measured 4 cm from the outlet orifices of the nozzle has a principle deposition zone of less than 3 mm.

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

11. The nozzle of claim 1, wherein drug product inlet is contiguous with the proximal end of the nozzle.

12. A method for delivering a drug product to an olfactory region of a nasal cavity, the method comprising:

providing a nozzle, the nozzle having a proximal end and a distal end, a drug product inlet in fluid connection with the proximal end of the nozzle and configured to receive a mixture of a propellant and the drug product, five channels contiguous with the drug product inlet and with five circular outlet orifices arranged in a pentagon at the distal end of the nozzle, each channel for carrying the drug product;

providing a container containing a propellant in fluid communication with the drug product inlet of the nozzle, the propellant configured to propel the drug product from the drug product inlet though the channels and out the five circular outlet orifices;

providing a drug product at the drug product inlet of the nozzle; and

dispensing the propellant to propel the drug product from the drug product inlet through the channels and out the five circular outlet orifices;

wherein each of the five channels generates a corresponding stream of drug product that together form a narrow drug plume upon exiting distal end of the nozzle, wherein an angle of the narrow drug plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree, or about 0 degree.

13. The method of claim 12, wherein the drug product is a liquid or powder.

14. The method of claim 12, wherein the drug product inlet is contiguous with the proximal end of the nozzle.