US2014144442A1PendingUtilityA1

Nasal administration

Assignee: OPTINOSE ASPriority: Jan 19, 2006Filed: Jan 29, 2014Published: May 29, 2014
Est. expiryJan 19, 2026(expired)· nominal 20-yr term from priority
H01M 2008/1293H01M 4/861H01M 4/8657H01M 4/8642A61M 11/00A61M 15/0021H01M 4/9066A61M 2202/04A61M 15/0065A61M 16/0493A61M 15/009A61M 15/0098H01M 8/0247H01M 8/023H01M 2004/8684A61K 31/404A61M 15/08A61M 2202/064A61M 16/20A61M 15/0091A61M 16/049Y02E60/50
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Claims

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 for insertion into a nasal airway of a subject and comprising an outlet unit which includes a nozzle 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

exact text as granted — not AI-modified
What we claim are: 
     
         1 . A delivery device for providing for delivery of substance to the central nervous system (CNS) of a subject, the delivery device comprising:
 a nosepiece unit for insertion into a nasal airway of a subject and comprising an outlet unit which includes a nozzle 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 which is posterior of the nasal valve and above the inferior meatus, and thereby provides a CNS effect which is significantly greater than that predicted from a counterpart blood plasma concentration of the substance;   wherein the substance comprises sumatriptan or its pharmaceutically-acceptable derivatives or analogues.   
     
     
         2 . The delivery device of  claim 1 , wherein the nozzle is configured to deliver a powder aerosol. 
     
     
         3 . The delivery device of  claim 1 , further comprising:
 a mouthpiece through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject.   
     
     
         4 . The delivery device of  claim 3 , wherein the outlet unit further comprises a delivery channel which is fluidly connected to the mouthpiece, whereby exhaled air from an exhalation breath of the subject is delivered through the nosepiece unit into the nasal airway of the subject. 
     
     
         5 . The delivery device of  claim 1 , wherein the substance supply unit is breath actuated. 
     
     
         6 . The delivery device of  claim 1 , wherein the delivery device is configured such that at least 40% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region of the nasal airway. 
     
     
         7 . The delivery device of  claim 1 , wherein the delivery device is configured such that at least 50% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region of the nasal airway. 
     
     
         8 . The delivery device of  claim 1 , wherein the outlet unit includes no cuff member which obstructs a region of the nasal airway which is anterior of the nasal valve. 
     
     
         9 . The delivery device of  claim 1 , wherein the ratio of the peak CNS effect to the peak blood plasma concentration is at least 2 times that achieved using intravenous (IV) delivery. 
     
     
         10 . The delivery device of  claim 1 , wherein the ratio of the peak CNS effect to the peak blood plasma concentration is at least 3 times that achieved using intravenous (IV) delivery. 
     
     
         11 . The delivery device of  claim 1 , wherein the substance is for the treatment of a condition which requires a rapid onset of action in order to ameliorate or abort a CNS event. 
     
     
         12 . The delivery device of  claim 1 , wherein the substance is for the treatment of migraine.

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