Nasal spray device

Abstract

A nasal spray device for the delivery of a pharmaceutical formulation to the nasal cavity in metered doses. The device includes: a pressurised aerosol canister including a vial containing a pharmaceutical formulation including an active ingredient, a propellant and, optionally, a co-solvent, the aerosol canister further including a metering valve having a valve stem; and an actuator for the aerosol canister, the actuator including a stem block having a receptacle into which the valve stem of metering valve of the aerosol canister is received and axially located and being displaceable relative to the vial of the aerosol canister to actuate the metering valve of the aerosol canister, a sump extending below the receptacle, the stem block further defining a discharge orifice for the pharmaceutical formulation and a transfer channel through which a dispensed dose of the pharmaceutical formulation is able to pass from the sump to the discharge orifice.

1 . A nasal spray device for the delivery of a pharmaceutical formulation to a nasal cavity in metered doses, the device comprising:
 a pressurised aerosol canister including a vial containing a pharmaceutical formulation comprising an active ingredient, a propellant and, optionally, a co-solvent, the aerosol canister further including a metering valve having a valve stem; and   an actuator for the aerosol canister, the actuator including a stem block having a receptacle into which the valve stem of metering valve of the aerosol canister is received and axially located and being displaceable relative to the vial of the aerosol canister to actuate the metering valve of the aerosol canister, a sump extending below the receptacle, the stem block further defining a discharge orifice for the pharmaceutical formulation and a transfer channel through which a dispensed dose of the pharmaceutical formulation is able to pass from the sump to the discharge orifice,   wherein the actuator further comprises a delivery outlet for an aerosol plume, the discharge orifice being arranged to direct the aerosol plume through the delivery outlet, and wherein the device is adapted to produce an aerosol plume for a dispensed dose having a spray force value no greater than 40 mN measured at a distance of 30 mm from the discharge orifice.   
     
     
         2 . A nasal spray device as claimed in  claim 1 , wherein the discharge orifice has a diameter of 0.15 to 0.65 mm. 
     
     
         3 . A nasal spray device as claimed in  claim 1 , wherein a maximum transverse dimension of the transfer channel is greater than a diameter of the discharge orifice. 
     
     
         4 . A nasal spray device as claimed in  claim 1 , wherein a maximum transverse dimension of the transfer channel is from 1.0 to 3.0 mm. 
     
     
         5 . A nasal spray device as claimed in  claim 1 , wherein the transfer channel has a circular cross-section. 
     
     
         6 . A nasal spray device as claimed in  claim 1 , wherein the transfer channel has a transverse dimension which tapers down towards an end of the discharge orifice. 
     
     
         7 . A nasal spray device as claimed in  claim 1 , wherein the transfer channel has a length of 3 to 20 mm. 
     
     
         8 . A nasal spray device as claimed in  claim 1 , wherein the discharge orifice has a length of 0.5 to 1.0 mm. 
     
     
         9 . A nasal spray device as claimed in  claim 1 , wherein the transfer channel has a first part in fluid communication with the sump of the stem block and a second part in fluid communication with the discharge orifice, the second part and the discharge orifice being defined by a separate insert received into an opening formed in the stem block of the actuator. 
     
     
         10 . A nasal spray device as claimed in  claim 1 , wherein the discharge orifice has a diameter of 0.15 to 0.65 mm and a length of 0.5 to 1.0 mm, and wherein the transfer channel has a transverse dimension which tapers down towards an end of the discharge orifice. 
     
     
         11 . A nasal spray device as claimed in  claim 1 , wherein the co-solvent is present at 0.5 to 20% w/w, based on a total weight of the pharmaceutical formulation. 
     
     
         12 . A nasal spray device as claimed in  claim 1 , wherein the active ingredient is beclomethasone dipropionate, the propellant is selected from P134a, P227 or mixtures thereof, or other pressurised gases, and the co-solvent is present and is anhydrous ethanol. 
     
     
         13 . Use of a nasal spray device according to  claim 1  for the delivery of a pharmaceutical formulation to the nasal cavity in metered doses. 
     
     
         14 . A nasal spray device as claimed in  claim 1 , wherein the pharmaceutical formulation is a solution formulation. 
     
     
         15 . A nasal spray device as claimed in  claim 1 , wherein the pharmaceutical formulation is a suspension formulation.