# US 10,478,574 B2 · Nasal administration > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,574 B2 - Document ID: US10478574B2 - Status: Granted - Kind: B2 - Application number: 12/161,466 - Filed: 2006-01-19 - Published: 2011-05-19 - Granted: 2019-11-19 - Earliest claimed: 2006-01-19 - Assignees: OptiNose AS - Applicants: Per Gisle Djupesland; Roderick Peter Hafner - Inventors: Per Gisle Djupesland; Roderick Peter Hafner - Web page: https://patentgrep.com/patent/US10478574B2 ## CPC - A61M 15/08: Inhaling devices inserted into the nose - A61K 31/404: Indoles, e.g. pindolol - A61M 15/0021: {Mouthpieces therefor} - A61M 15/0091: {mechanically breath-triggered} - A61M 15/0098: {Activated by exhalation} - A61M 16/049: {Mouthpieces} - A61M 16/0493: {with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block} - A61M 16/20: Valves specially adapted to medical respiratory devices - H01M 4/861: {with a gradient in the porosity} - H01M 4/8642: {Gradient in composition} - H01M 4/8657: {layered} - H01M 4/9066: {of metal-ceramic composites or mixtures, e.g. cermets} - H01M 8/023: Porous and characterised by the material - H01M 8/0247: characterised by the form (characterised by a channel configuration H01M8/0258) - A61M 11/00: Sprayers or atomisers specially adapted for therapeutic purposes (in general B05B; {aerosol containers B65D83/14}) - A61M 15/0065: {Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52)} - A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)} - A61M 2202/04: Liquids - A61M 2202/064: Powder - H01M 2004/8684: {Negative electrodes} - H01M 2008/1293: {Fuel cells with solid oxide electrolytes} - Y02E 60/50: Fuel cells - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - H01M: PROCESSES OR MEANS, e.g. BATTERIES, FOR THE DIRECT CONVERSION OF CHEMICAL ENERGY INTO ELECTRICAL ENERGY - Y02E: REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The method of claim 1, wherein the pharmaceutical composition is an aerosol spray. ### Claim 3 (depends on 2) The method of claim 2, wherein the aerosol spray is a liquid. ### Claim 4 (depends on 2) The method of claim 2, wherein the aerosol spray is a powder. ### Claim 5 (depends on 1) The method of claim 1, wherein the pharmaceutical composition is a liquid jet. ### Claim 6 (depends on 1) The method of claim 1, wherein the pharmaceutical composition is a dopamine agonist. ### Claim 7 (depends on 1) The method of claim 1, wherein the pharmaceutical composition is a triptan. ### Claim 8 (depends on 7) The method of claim 7, wherein the triptan is sumatriptan. ### Claim 9 (depends on 1) The method of claim 1, wherein the pharmaceutical composition has activity on a learning pathway. ### Claim 10 (depends on 1) The method of claim 1, wherein the pharmaceutical composition comprises vasopressin or its pharmaceutically-acceptable derivatives or analogues. ### Claim 11 (depends on 1) The method of claim 1, wherein the pharmaceutical composition comprises desmopressin or its pharmaceutically-acceptable derivatives or analogues. ### Claim 12 (depends on 1) The method of claim 1, wherein the pharmaceutical composition is an acetylcholinesterase inhibitor. ### Claim 13 (depends on 1) The method of claim 1, wherein the pharmaceutical composition comprises rivastigmine or its pharmaceutically-acceptable derivatives or analogues. ### Claim 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. ### Claim 15 (depends on 14) The method of claim 14, wherein the pharmaceutical composition is an aerosol spray. ### Claim 16 (depends on 15) The method of claim 15, wherein the aerosol spray is a liquid. ### Claim 17 (depends on 15) The method of claim 15, wherein the aerosol spray is a powder. ### Claim 18 (depends on 14) The method of claim 14, wherein the pharmaceutical composition is a liquid jet. ### Claim 19 (depends on 14) The method of claim 14, wherein the pharmaceutical composition is a dopamine agonist. ### Claim 20 (depends on 14) The method of claim 14, wherein the pharmaceutical composition is a triptan. ### Claim 21 (depends on 20) The method of claim 20, wherein the triptan is sumatriptan. ### Claim 22 (depends on 14) The method of claim 14, wherein the pharmaceutical composition has activity on a learning pathway. ### Claim 23 (depends on 14) The method of claim 14, wherein the pharmaceutical composition comprises vasopressin or its pharmaceutically-acceptable derivatives or analogues. ### Claim 24 (depends on 14) The method of claim 14, wherein the pharmaceutical composition comprises desmopressin or its pharmaceutically-acceptable derivatives or analogues. ### Claim 25 (depends on 14) The method of claim 14, wherein the pharmaceutical composition is an acetylcholinesterase inhibitor. ### Claim 26 (depends on 14) The method of claim 14, wherein the pharmaceutical composition comprises rivastigmine or its pharmaceutically-acceptable derivatives or analogues. ### Claim 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. ### Claim 28 (depends on 27) The method of claim 27, wherein the pharmaceutical composition is an aerosol spray. ### Claim 29 (depends on 28) The method of claim 28, wherein the aerosol spray is a liquid. ### Claim 30 (depends on 28) The method of claim 28, wherein the aerosol spray is a powder. ### Claim 31 (depends on 27) The method of claim 27, wherein the pharmaceutical composition is a liquid jet. ### Claim 32 (depends on 27) The method of claim 27, wherein the pharmaceutical composition is a dopamine agonist. ### Claim 33 (depends on 27) The method of claim 27, wherein the pharmaceutical composition is a triptan. ### Claim 34 (depends on 33) The method of claim 33, wherein the triptan is sumatriptan. ### Claim 35 (depends on 27) The method of claim 27, wherein the pharmaceutical composition has activity on a learning pathway. ### Claim 36 (depends on 27) The method of claim 27, wherein the pharmaceutical composition comprises vasopressin or its pharmaceutically-acceptable derivatives or analogues. ### Claim 37 (depends on 27) The method of claim 27, wherein the pharmaceutical composition comprises desmopressin or its pharmaceutically-acceptable derivatives or analogues. ### Claim 38 (depends on 27) The method of claim 27, wherein the pharmaceutical composition is an acetylcholinesterase inhibitor. ### Claim 39 (depends on 27) The method of claim 27, wherein the pharmaceutical composition comprises rivastigmine or its pharmaceutically-acceptable derivatives or analogues.