Nasal delivery

• US 9,949,923 B2
• Filed: 03/15/2012
• Issued: 04/24/2018
• Est. Priority Date: 03/15/2011
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Haghighatian, Mina
• Application Number:
  US14/005,363
• Publication Number:
  US 20140073562A1
• Time in Patent Office: 2,231 Days
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/4174 Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 38/12 Cyclic peptides , e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C A61K38/043 - A61K38/046 take precedence
• CPC Class Codes: A61K 38/17 from animals; from humans enzyme inhibitors A61K38/005
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/064 Powder

Abstract

A nasal delivery device for and method of delivering a substance, preferably comprising oxytocin, non-peptide agonists thereof and antagonists thereof, preferably as one of a liquid, as a suspension or solution, or a powder to the nasal airway of a subject, preferably the posterior region of the nasal airway, and preferably the upper posterior region of the nasal airway which includes the olfactory bulb and the trigeminal nerve, and preferably in the treatment of neurological conditions and disorders.

Claims

1. A method of treating 22q11.2 deletion syndrome, comprising

delivering from about 1 IU to about 100 IU of a substance selected from the group consisting of oxytocin, carbetocin, and demoxytocin to the upper posterior, olfactory region of the nasal airway.

2. The method of claim 1, wherein the substance is delivered as a powder.

3. The method of claim 1, wherein the substance is delivered as a liquid.

4. The method of claim 1, wherein the substance is delivered as a powder, followed by application of a liquid.

5. The method of claim 1, wherein the substance includes a thickening agent, which thickens following delivery on exposure to moisture, thereby increasing residency of the substance at the upper posterior, olfactory region of the nasal airway, wherein the thickening agent comprises pectin, agar-agar, lignin, algin, gums, and/or cellulose.

6. The method of claim 1, wherein the substance is delivered in a once-daily administration or twice-daily administration.

7. The method of claim 1, wherein the delivery of the substance is targeted to provide for one or both of nose-to-brain (N2B) and systemic delivery.

8. The method of claim 1, wherein the substance is mixed with lactose.

9. A method of treating 22q11.2 deletion syndrome, comprising delivering oxytocin to the upper posterior, olfactory region of the nasal airway.

10. The method of claim 9, wherein about 1 IU to about 100 IU of oxytocin is delivered.

11. The method of claim 9, wherein the oxytocin is delivered as a powder.

12. The method of claim 9, wherein the oxytocin is delivered as a liquid.

13. The method of claim 9, wherein the oxytocin is delivered as a powder, followed by application of a liquid.

14. The method of claim 9, further including delivering a thickening agent, which thickens following delivery on exposure to moisture to thereby increase residency of oxytocin at the upper posterior, olfactory region of the nasal airway.

15. The method of claim 14, wherein the thickening agent comprises pectin, agar-agar, lignin, algin, gums, and/or cellulose.

16. The method of claim 9, wherein delivery of the oxytocin is targeted to provide for one or both of nose-to-brain (N2B) and systemic delivery.

17. The method of claim 9, further including delivering lactose with the oxytocin.