Claims for Patent: 10,478,574

Summary for Patent: 10,478,574

Title:	Nasal administration
Abstract:	A delivery device for and method of providing for delivery of substance to the central nervous system (CNS) of a subject, the delivery device comprising: a nosepiece unit (17) for insertion into a nasal airway (1) of a subject and comprising an outlet unit (21) which includes a nozzle (25) for delivering substance into the nasal airway of the subject; and a substance supply unit which is operable to deliver a dose of substance to the nozzle: wherein the delivery device is configured such that at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the nasal airway, thereby providing a CNS concentration of the substance, and hence CNS effect, which is significantly greater than that which would be predicted from a counterpart blood plasma concentration of the substance.
Inventor(s):	Djupesland; Per Gisle (Oslo, NO), Hafner; Roderick Peter (Wiltshire, GB)
Assignee:	OptiNose AS (Oslo, NO)
Application Number:	12/161,466
Patent Claims:	1. A method of treating a subject by delivering a pharmaceutical composition to a nasal airway of the subject, comprising: fitting a mouthpiece to a mouth of the subject; fitting a nosepiece unit to a first nostril of the subject, wherein the nosepiece unit comprises: a nosepiece which is configured to guide the nosepiece unit into a first nasal passageway of the subject; a delivery channel which is fluidly connected between the mouthpiece and the nosepiece, such that an exhalation air flow can be delivered from the mouthpiece through the delivery channel, and through the nosepiece when the subject exhales through the mouthpiece; and a supply unit which is configured to deliver a dose of the pharmaceutical composition; exhaling with an exhalation breath of the subject through the mouthpiece to cause closure of an oropharyngeal velum of the subject, wherein the exhalation breath of the subject produces the exhalation air flow which exceeds a predetermined flow rate and flows through the first nostril of the subject and into the first nasal passageway of the subject, around a posterior margin of a nasal septum of the subject and into a second nasal passageway of the subject, and out of a second nostril of the subject; delivering, during a time when the exhalation breath of the subject produces the exhalation air flow, the dose of the pharmaceutical composition to the nasal airway of the subject such that at least 30% of the dose of the pharmaceutical composition, as initially deposited in the nasal airway of the subject, is deposited at an upper posterior region of the nasal airway of the subject, which is posterior of a nasal valve of the subject and above an inferior meatus of the subject. 2. The method of claim 1, wherein the pharmaceutical composition is an aerosol spray. 3. The method of claim 2, wherein the aerosol spray is a liquid. 4. The method of claim 2, wherein the aerosol spray is a powder. 5. The method of claim 1, wherein the pharmaceutical composition is a liquid jet. 6. The method of claim 1, wherein the pharmaceutical composition is a dopamine agonist. 7. The method of claim 1, wherein the pharmaceutical composition is a triptan. 8. The method of claim 7, wherein the triptan is sumatriptan. 9. The method of claim 1, wherein the pharmaceutical composition has activity on a learning pathway. 10. The method of claim 1, wherein the pharmaceutical composition comprises vasopressin or its pharmaceutically-acceptable derivatives or analogues. 11. The method of claim 1, wherein the pharmaceutical composition comprises desmopressin or its pharmaceutically-acceptable derivatives or analogues. 12. The method of claim 1, wherein the pharmaceutical composition is an acetylcholinesterase inhibitor. 13. The method of claim 1, wherein the pharmaceutical composition comprises rivastigmine or its pharmaceutically-acceptable derivatives or analogues. 14. A method of treating a subject by delivering a pharmaceutical composition to a nasal airway of the subject, comprising: fitting a mouthpiece to a mouth of the subject; fitting a nosepiece unit to a first nostril of the subject, wherein the nosepiece unit comprises: a nosepiece which is configured to guide the nosepiece unit into a first nasal passageway of the subject; a delivery channel which is fluidly connected between the mouthpiece and the nosepiece, such that an exhalation air flow can be delivered from the mouthpiece through the delivery channel, and through the nosepiece when the subject exhales through the mouthpiece; and a supply unit which is configured to deliver a dose of the pharmaceutical composition; exhaling with an exhalation breath of the subject through the mouthpiece to cause closure of an oropharyngeal velum of the subject, wherein the exhalation breath of the subject produces the exhalation air flow which exceeds a predetermined flow rate and flows through the first nostril of the subject and into the first nasal passageway of the subject, around a posterior margin of a nasal septum of the subject and into a second nasal passageway of the subject, and out of a second nostril of the subject; delivering, during a time when the exhalation breath of the subject produces the exhalation air flow, the dose of the pharmaceutical composition to the nasal airway of the subject such that at least 40% of the dose of the pharmaceutical composition, as initially deposited in the nasal airway of the subject, is deposited at an upper posterior region of the nasal airway of the subject, which is posterior of a nasal valve of the subject and above an inferior meatus of the subject. 15. The method of claim 14, wherein the pharmaceutical composition is an aerosol spray. 16. The method of claim 15, wherein the aerosol spray is a liquid. 17. The method of claim 15, wherein the aerosol spray is a powder. 18. The method of claim 14, wherein the pharmaceutical composition is a liquid jet. 19. The method of claim 14, wherein the pharmaceutical composition is a dopamine agonist. 20. The method of claim 14, wherein the pharmaceutical composition is a triptan. 21. The method of claim 20, wherein the triptan is sumatriptan. 22. The method of claim 14, wherein the pharmaceutical composition has activity on a learning pathway. 23. The method of claim 14, wherein the pharmaceutical composition comprises vasopressin or its pharmaceutically-acceptable derivatives or analogues. 24. The method of claim 14, wherein the pharmaceutical composition comprises desmopressin or its pharmaceutically-acceptable derivatives or analogues. 25. The method of claim 14, wherein the pharmaceutical composition is an acetylcholinesterase inhibitor. 26. The method of claim 14, wherein the pharmaceutical composition comprises rivastigmine or its pharmaceutically-acceptable derivatives or analogues. 27. A method of treating a subject by delivering a pharmaceutical composition to a nasal airway of the subject, comprising: fitting a mouthpiece to a mouth of the subject; fitting a nosepiece unit to a first nostril of the subject, wherein the nosepiece unit comprises: a nosepiece which is configured to guide the nosepiece unit into a first nasal passageway of the subject; a delivery channel which is fluidly connected between the mouthpiece and the nosepiece, such that an exhalation air flow can be delivered from the mouthpiece through the delivery channel, and through the nosepiece when the subject exhales through the mouthpiece; and a supply unit which is configured to deliver a dose of the pharmaceutical composition; exhaling with an exhalation breath of the subject through the mouthpiece to cause closure of an oropharyngeal velum of the subject, wherein the exhalation breath of the subject produces the exhalation air flow which exceeds a predetermined flow rate and flows through the first nostril of the subject and into the first nasal passageway of the subject, around a posterior margin of a nasal septum of the subject and into a second nasal passageway of the subject, and out of a second nostril of the subject; delivering, during a time when the exhalation breath of the subject produces the exhalation air flow, the dose of the pharmaceutical composition to the nasal airway of the subject such that at least 50% of the dose of the pharmaceutical composition, as initially deposited in the nasal airway of the subject, is deposited at an upper posterior region of the nasal airway of the subject, which is posterior of a nasal valve of the subject and above an inferior meatus of the subject. 28. The method of claim 27, wherein the pharmaceutical composition is an aerosol spray. 29. The method of claim 28, wherein the aerosol spray is a liquid. 30. The method of claim 28, wherein the aerosol spray is a powder. 31. The method of claim 27, wherein the pharmaceutical composition is a liquid jet. 32. The method of claim 27, wherein the pharmaceutical composition is a dopamine agonist. 33. The method of claim 27, wherein the pharmaceutical composition is a triptan. 34. The method of claim 33, wherein the triptan is sumatriptan. 35. The method of claim 27, wherein the pharmaceutical composition has activity on a learning pathway. 36. The method of claim 27, wherein the pharmaceutical composition comprises vasopressin or its pharmaceutically-acceptable derivatives or analogues. 37. The method of claim 27, wherein the pharmaceutical composition comprises desmopressin or its pharmaceutically-acceptable derivatives or analogues. 38. The method of claim 27, wherein the pharmaceutical composition is an acetylcholinesterase inhibitor. 39. The method of claim 27, wherein the pharmaceutical composition comprises rivastigmine or its pharmaceutically-acceptable derivatives or analogues.