US2021220262A1PendingUtilityA1

Nasal delivery

70
Assignee: OPTINOSE ASPriority: Mar 15, 2011Filed: Jan 21, 2021Published: Jul 22, 2021
Est. expiryMar 15, 2031(~4.7 yrs left)· nominal 20-yr term from priority
A61M 15/08A61K 38/17A61K 9/0043A61K 31/198A61K 31/551A61K 38/12A61M 2202/0468A61M 2202/064A61K 31/4174A61M 15/0098
70
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Claims

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

exact text as granted — not AI-modified
1 - 63 . (canceled) 
     
     
         64 . A method of delivering a dose of powdered oxytocin to an upper posterior, olfactory region of a nasal airway of a subject with a nasal delivery device, the method comprising:
 causing a nosepiece of the device to be fitted in a nostril of the subject, the device further including a mouthpiece, a medicament supply unit, and a tubular section coupling the nosepiece and the mouthpiece;   causing the subject to exhale through the mouthpiece and generate an exhalation flow that flows (a) through the tubular section and creates a positive pressure in an oral cavity of the subject sufficient to cause closure of an oropharyngeal velum of the subject and (b) through the nosepiece and creates a bi-directional flow of exhalation breath through a nasal cavity of the subject when the nosepiece is fitted in the nostril;   causing a flow of gas from the medicament supply unit to entrain the dose of powdered oxytocin within the flow of gas and expel the dose of powdered oxytocin and flow of gas through the nosepiece; and   causing a flow of liquid from the medicament supply unit through the nosepiece after causing the flow of gas from the medicament supply unit.   
     
     
         65 . The method of  claim 64 , further including causing a thickening agent to be expelled through the nosepiece with the dose of powdered oxytocin. 
     
     
         66 . The method of  claim 65 , wherein the thickening agent thickens after exposure to moisture, providing for increased residency at the upper posterior, olfactory region of the nasal airway of the subject. 
     
     
         67 . The method of  claim 65 , wherein the thickening agent comprises at least one of pectin, agar-agar, lignin, algin, gums, or cellulose. 
     
     
         68 . The method of  claim 64 , further including causing lactose to be expelled through the nosepiece with the dose of powdered oxytocin. 
     
     
         69 . The method of  claim 64 , wherein the dose of powdered oxytocin ranges from about 1 IU to about 100 IU. 
     
     
         70 . The method of  claim 64 , wherein the dose of powdered oxytocin ranges from about 5 IU to about 80 IU. 
     
     
         71 . The method of  claim 64 , wherein the dose of powdered oxytocin ranges from about 5 IU to about 50 IU. 
     
     
         72 . The method of  claim 64 , wherein the dose of powdered oxytocin ranges from about 5 IU to about 20 IU. 
     
     
         73 . The method of  claim 64 , wherein the dose of powdered oxytocin is delivered once daily. 
     
     
         74 . The method of  claim 64 , wherein the dose of powdered oxytocin is delivered twice daily. 
     
     
         75 . The method of  claim 64 , wherein the method is performed to provide for treatment of 22q11.2 deletion syndrome. 
     
     
         76 . A method of delivering a dose of powdered oxytocin to an upper posterior, olfactory region of a nasal airway of a subject with a nasal delivery device, the method comprising:
 fitting a nosepiece of the device in a nostril of the subject, the device including a mouthpiece, a medicament supply unit, and a tubular section coupling the nosepiece and the mouthpiece;   exhaling through the mouthpiece to generate an exhalation flow that flows (a) through the tubular section and creates a positive pressure in an oral cavity of the subject sufficient to cause closure of an oropharyngeal velum of the subject and (b) through the nosepiece and creates a bi-directional flow of exhalation breath through a nasal cavity of the subject when the nosepiece is fitted in the nostril; and   supplying, via a medicament supply unit, (1) a gas flow that entrains the dose of powdered oxytocin within the flow of gas and expels the dose of powdered oxytocin and flow of gas through the nosepiece and (2) a liquid flow through the nosepiece, subsequent to expulsion of the flow of gas from the medicament supply unit.   
     
     
         77 . The method of  claim 76 , further including expelling a thickening agent through the nosepiece with the dose of powdered oxytocin. 
     
     
         78 . The method of  claim 77 , wherein the thickening agent thickens after exposure to moisture, providing for increased residency at the upper posterior, olfactory region of the nasal airway of the subject. 
     
     
         79 . The method of  claim 77 , wherein the thickening agent comprises at least one of pectin, agar-agar, lignin, algin, gums, or cellulose. 
     
     
         80 . The method of  claim 76 , further including expelling lactose through the nosepiece with the dose of powdered oxytocin. 
     
     
         81 . The method of  claim 76 , wherein the dose of powdered oxytocin ranges from about 1 IU to about 100 IU. 
     
     
         82 . The method of  claim 76 , wherein the dose of powdered oxytocin ranges from about 5 IU to about 80 IU. 
     
     
         83 . The method of  claim 76 , wherein the dose of powdered oxytocin is delivered once daily. 
     
     
         84 . The method of  claim 76 , wherein the dose of powdered oxytocin is delivered twice daily. 
     
     
         85 . The method of  claim 76 , wherein the method is performed to provide for treatment of 22q11.2 deletion syndrome.

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