NASAL DELIVERY

• US 20110318345A1
• Filed: 09/15/2009
• Published: 12/29/2011
• Est. Priority Date: 09/15/2008
• Status: Abandoned Application

• Current Assignee: OptiNose AS (OptiNose, Inc.)
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Application Number:
  US13/063,963
• Publication Number:
  US 20110318345A1
• Time in Patent Office: Days
• US Class Current: 424/134.1
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

substances and the nasal administration thereof, in particular as one of a liquid, as a suspension or solution, or a powder, to the nasal airway of a subject, in particular the posterior region of the nasal airway, and in particular the upper posterior region of the nasal airway, which includes the olfactory bulb, in particular in the treatment of neurological conditions and disorders.

Claims

1. Nasal administration of angiotensin antagonists, angiotensin (AT) II receptor antagonists (angiotensin receptor blockers), AT1 receptor antagonists and sartans, such as losartan, angiotensin-converting enzyme (ACE) inhibitors, glycine receptor antagonists, anti-histamines, in particular non-selective antihistamines, such as dimebon (2,3,4,5-tetrahydro-2,8-dimethyl-5-[2-(6-methyl 3-pyridinypethyl]-1H-pyrido[4,3-b]indole provided as the dichloride salt), morphine, glycogen synthase kinase 3 (GSK3) inhibitors, such as substituted pyrazolo[3,4-b]pyridin-6-ones, substituted 4-amino[1,2,4]triazolo[4,3-a]quinoxalines, pyrimidine and pyridine derivatives and lithium, tumor necrosis factor (TNF) blockers, such as etanercept, infliximab and adalimumab, oxytocin, or cells, including stern cells and glioma cells, for the treatment of neurological diseases and conditions, including neurodegenerative diseases and conditions, such as Alzheimer'"'"'s disease, Huntington'"'"'s disease, Parkinson'"'"'s disease, dementia and stroke, bi-polar disorder, diabetes, schizophrenia, depression, anxiety, hair loss, cancer, obesity, atherosclerotic cardiovascular disease, essential hypertension, polycystic ovary syndrome, syndrome X, ischemia, especially cerebral ischemia, traumatic brain injury, immunodeficiency, autism, sexual dysfunction, regulation of maternal behaviour, regulation of female sexual behaviour, regulation of male sexual behaviour, regulation of social behaviour, including regulation of male and female aggression, promoting social memory, including social recognition and pair bonding, promoting learning, promoting memory, suppression of fever, or by way of pain relief, such as in the treatment of breakthrough pain.

2. The nasal administration of claim 1, wherein the administration is to the posterior region of the nasal airway.

3. The nasal administration of claim 2, wherein the administration Is to the upper posterior region of the nasal airway.

4. The nasal administration of claim 3, wherein the administration is to the olfactory region.

5. The nasal administration of any of claims 1 to 4, comprising the steps of:

fitting a nosepiece unit to one nostril of a subject, the nosepiece unit including a nosepiece which is inserted into the one nostril of a subject and a nozzle through which substance is delivered to the respective nasal cavity; and

delivering substance through the nozzle into the nasal cavity.

6. The nasal administration of claim 5, further comprising the step of:

expanding the nasal valve.

7. The nasal administration of claim 6, wherein the nosepiece is configured to extend into the nasal valve and provide for expansion thereof.

8. The nasal administration of any of claims 5 to 8, further comprising the step of:

the subject exhaling through a mouthpiece unit such as to cause closure of the oropharyngeal velum of the subject.

9. The nasal administration of claim 8, wherein the nosepiece is fluidly connected to the mouthpiece unit, such that exhaled air from an exhalation breath is delivered through the nosepiece.

10. The nasal administration of any of claims 5 to 8, further comprising the step of:

delivering a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, through the nosepiece.

11. The nasal administration of any of claims 5 to 10, wherein the nozzle provides for the delivery of a single jet or a plurality of jets, either as a liquid jet or a powder jet.

12. The nasal administration of any of claims 5 to 10, wherein the nozzle provides for the delivery of an aerosol spray, either as a liquid spray or a powder spray.

13. The nasal administration of any of claims 5 to 12, further comprising the step of:

manually actuating the delivery unit.

14. The nasal administration of any of claims 5 to 12, further comprising the step of:

actuating the delivery unit in response to oral exhalation by the subject.

15. The nasal administration of any of claims 5 to 12, further comprising the step of:

actuating the delivery unit in response to nasal exhalation by the subject.

16. The nasal adminitration of claim 14 or 15, wherein the actuation mechanism is configured such as to be actuated in response to the generation of a predeterminable pressure in the nasal cavity.

17. Angiotensin antagonists, anglotensin (AT) H receptor antagonists (angiotensin receptor blockers), AT1 receptor antagonists and sartans, such as losartan, angiotensin-converting enzyme (ACE) inhibitors, glycine receptor antagonists, anti-histamines, in particular non-selective antihistamines, such as dimebon (2,3,4,5-tetra hydro-2,8-dimethyl-5-[2-(6-methyl 3-pyridinyl)ethyl]-1H-pyrido[4,3-b]indole provided as the dichloride salt), morphine, glycogen synthase kinase 3 (GSK3) inhibitors, such as substituted pyrazolo[3,4-b]pyridin-6-ones, substituted 4-amino[1,2,4]triazolo[4,3-a]quinoxalines, pyrimidine and pyridine derivatives and lithium, tumor necrosis factor (TNF) blockers, such as etanercept, infliximab and adalimumab, oxytocin, or cells, including stem cells and glioma cells, for the treatment of neurological diseases and conditions, including neurodegenerative diseases and conditions, such as Alzheimer'"'"'s disease, Huntington'"'"'s disease, Parkinson'"'"'s disease, dementia and stroke, bi-polar disorder, diabetes, schizophrenia, depression, anxiety, hair loss, cancer, obesity, atherosclerotic cardiovascular disease, essential hypertension, polycystic ovary syndrome, syndrome X, ischemia, especially cerebral ischemia, traumatic brain injury, immunodeficiency, autism, sexual dysfunction, regulation of maternal behaviour, regulation of female sexual behaviour, regulation of male sexual behaviour, regulation of social behaviour, including regulation of male and female aggression, promoting social memory, including social recognition and pair bonding, promoting learning, promoting memory, suppression of fever, or by way of pain relief, such as in the treatment of breakthrough pain.