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 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.

What we claim are: 
     
         1 . A method of delivering substance to the central nervous system (CNS) of a subject, the method comprising the steps of:
 inserting a nosepiece unit into a nasal airway of a subject, wherein the nosepiece unit comprises an outlet unit which includes a nozzle for delivering substance into the nasal airway of the subject; and   delivering a dose of substance to the nozzle;   wherein 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, thereby providing 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 method of  claim 1 , wherein the nozzle is configured to deliver a powder aerosol. 
     
     
         3 . The method of  claim 1 , further comprising the step of:
 the subject exhaling through a mouthpiece to cause closure of the oropharyngeal velum of the subject.   
     
     
         4 . The method of  claim 3 , wherein the outlet unit 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 to entrain the delivered substance. 
     
     
         5 . The method of  claim 1 , wherein a dose of the substance is delivered in response to exhalation by the subject. 
     
     
         6 . The method of  claim 1 , wherein 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 method of  claim 6 , wherein 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 method of  claim 1 , wherein a fluid communication remains between a region of the nasal airway which is anterior of the nasal valve and a region of the nasal airway which is posterior of the nasal valve. 
     
     
         9 . The method of  claim 8 , wherein the region posterior of the nasal valve represents the posterior two-thirds of the nasal airway and the region anterior of the nasal valve represents the anterior one-third of the nasal airway. 
     
     
         10 . The method 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. 
     
     
         11 . The method 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. 
     
     
         12 . The method 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. 
     
     
         13 . The method of  claim 1 , wherein the substance is for the treatment of migraine. 
     
     
         14 . A method of delivering substance to the central nervous system (CNS) of a subject, the method comprising the steps of:
 inserting a nosepiece unit into a nasal airway of a subject, wherein the nosepiece unit comprises an outlet unit which includes a nozzle for delivering substance into the nasal airway of the subject, wherein the nozzle is configured to deliver a powder aerosol; and   the subject exhaling through a mouthpiece to cause closure of the oropharyngeal velum of the subject, wherein the outlet unit 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 to entrain and deliver a dose of substance to the nozzle;   wherein the substance comprises sumatriptan or its pharmaceutically-acceptable derivatives or analogues;   wherein 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, thereby providing a CNS effect which is significantly greater than that predicted from a counterpart blood plasma concentration of the substance.