Intranasal administration

Patent metadata

Field	Value
Publication number	US-11052204-B2
Application number	US-201514946389-A
Country	US
Kind code	B2
Filing date	Nov 19, 2015
Priority date	Nov 19, 2014
Publication date	Jul 6, 2021
Grant date	Jul 6, 2021

Abstract

A delivery device for and method of modulating a condition relating to sodal cognition and/or behaviour in a human subject using oxytocin, non-peptide agonists thereof and/or antagonists thereof, comprising: providing a nosepiece to a first nasal cavity of the subject; and providing a supply unit for administering less than 24 IU of oxytocin, non-peptide agonists thereof and/or antagonists thereof through the nosepiece to an upper region posterior of the nasal valve which is innervated by the trigeminal nerve.

First claim

The imvention claimed is:

1. A delivery device for modulating a condition in a human subject comprising:
a mouthpiece configured to fit within an oral cavity of the subject and permit the subject to exhale therethrough, whereby exhalation by the subject causes closure of the oropharyngeal velum of the subject;
a nosepiece fluidly connected to the mouthpiece, the nosepiece configured to fit within a nostril of the subject, wherein the device is configured to deliver an exhalation breath of the subject from the mouthpiece, through the nosepiece, and into a first nasal cavity of the subject; and
a multi-dose delivery pump manually actuatable, on each actuation, to deliver a metered dose of at least one of oxytocin, a non-peptide agonist of oxytocin, and a non-peptide antagonist of oxytocin through the nosepiece to an upper posterior region, posterior of the nasal valve, innervated by the trigeminal nerve, each dose containing no more than 24 IU.

2. The delivery device of claim 1 , wherein, when the exhalation breath of the subject is delivered through the nosepiece into the first nasal cavity of the subject, the exhalation breath acts to establish a flow through the first nasal cavity of the subject around a posterior margin of the subject, and out of a second nasal cavity of the subject.

3. The delivery device of claim 2 , wherein the exhalation breath is delivered substantially simultaneously with administration of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin.

4. The delivery device of claim 1 , wherein the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is a liquid.

5. The delivery device of claim 4 , wherein the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered as a spray.

6. The delivery device of claim 1 , wherein the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered as a powder.

7. The delivery device of claim 6 , wherein the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered as a spray.

8. The delivery device of claim 1 , wherein the oxytocin comprises desglycinamide oxytocin.

9. The delivery device of claim 1 , wherein the oxytocin comprises carbetocin.

10. The delivery device of claim 1 , wherein the oxytocin comprises demoxytocin.

11. The delivery device of claim 1 , wherein less than 15 IU of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered.

12. The delivery device of claim 1 , wherein less than 12 IU of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered.

13. The delivery device of claim 1 , wherein less than 10 IU of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered.

14. The delivery device of claim 1 , wherein more than 1 IU of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered.

15. The delivery device of claim 1 , wherein more than 2 IU of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered.

16. The delivery device of claim 1 , wherein more than 4 IU of the at least one of oxytocin, the non-peptide agonist of oxytocin, and the non-peptide antagonist of oxytocin is delivered.

17. A delivery device for modulating a condition in a human subject comprising:
a mouthpiece configured to fit within an oral cavity of the subject and permit the subject to exhale therethrough, whereby exhalation by the subject causes closure of the oropharyngeal velum of the subject;
a nosepiece fluidly connected to the mouthpiece, the nosepiece having a longitudinal axis and configured to fit within a nostril of the subject, the nosepiece comprising a body having a base portion, a tip, and a projection extending from the base portion, wherein the tip is configured to extend into the nasal valve of the subject and expand the nasal valve, wherein the device is configured to deliver an exhalation breath of a subject from the mouthpiece, through the nosepiece, and into a first nasal cavity of the subject; and
a delivery unit containing oxytocin and at least one of a non-peptide agonist of oxytocin, and a non-peptide antagonist of oxytocin.

18. The delivery device of claim 17 , wherein, when the exhalation breath of the subject is delivered through the nosepiece into the first nasal cavity of the subject, the exhalation breath acts to establish a flow through the first nasal cavity of the subject around a posterior margin of the subject, and out of a second nasal cavity of the subject.

19. The delivery device of claim 18 , wherein the exhalation breath is delivered substantially simultaneously with administration of the oxytocin and the at least one of non-peptide agonist of oxytocin and non-peptide antagonist of oxytocin.

20. The delivery device of claim 17 , wherein the oxytocin and the at least one of non-peptide agonist of oxytocin and non-peptide antagonist of oxytocin is a liquid.

21. The delivery device of claim 20 , wherein the oxytocin and the at least one of non-peptide agonist of oxytocin and non-peptide antagonist of oxytocin is delivered as a spray.

22. The delivery device of claim 17 , wherein the oxytocin and the at least one of non-peptide agonist of oxytocin and non-peptide antagonist of oxytocin is a powder.

23. The delivery device of claim 22 , wherein the oxytocin and the at least one of non-peptide agonist of oxytocin and non-peptide antagonist of oxytocin is delivered as a spray.

24. The delivery device of claim 17 , wherein the oxytocin comprises desglycinamide oxytocin.

25. The delivery device of claim 17 , wherein the oxytocin comprises carbetocin.

26. The delivery device of claim 17 , wherein the oxytocin comprises demoxytocin.

27. The delivery device of claim 17 , wherein the body part of the nosepiece defines a flow path through the nosepiece.

28. The delivery device of claim 17 , wherein the projection forms a portion of the tip of the nosepiece.

29. The delivery device of claim 17 , wherein the projection extends substantially parallel and offset with respect to the longitudinal axis of the nosepiece.

30. The delivery device of claim 17 , wherein the projection comprises a flat element with a first length in the sagittal direction and a second length in the lateral direction, the first length being greater than the second length.

31. The delivery device of claim 30 , wherein the first length is 1.5 times greater than the second length.

32. The delivery device of claim 30 , wherein the first length is 1.7 times greater than the second length.

33. The delivery device of claim 30 , wherein the first length is 1.9 times greater than the second length.

34. The delivery device of claim 30 , wherein the first length is 2 times greater than the second length.

35. The delivery device of claim 30 , wherein the projection includes a tapering cro

Assignees

• Djupesland Per Gisle
• Mahmoud Ramy A
• Andreassen Ole A
• Westlye Lars T
• Quintana Daniel S
• Smerud Knut T
• Sheldrake Colin David
• Optinose As

Inventors

• Djupesland Per Gisle
• Mahmoud Ramy A
• Andreassen Ole A
• Westlye Lars T
• Quintana Daniel S
• Smerud Knut T
• Sheldrake Colin David

Classifications

• A61M15/0098

  Activated by exhalation · CPC title

• A61M15/009

  using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08) · CPC title

• A61M15/0013

  with inhalation check valves · CPC title

• A61M2210/0618

  Nose · CPC title

• A61K38/22 Primary

  Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35) · CPC title