Claims for Patent: 10,188,811

Summary for Patent: 10,188,811

Title:	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.
Inventor(s):	Zeng; Xian-Ming (Miami, FL), Walsh; Declan (Co. Kilkenny, IE), Ly; Jade Ching-Ying (Miami, FL), Morales; Armando (Miami, FL)
Assignee:	TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. (Horsham, PA) IVAX PHARMACEUTICALS IRELAND (Waterford, IE)
Application Number:	14/865,823
Patent Claims:	1. A nasal spray device for the delivery of a pharmaceutical formulation to a nasal cavity in metered doses, the nasal spray device comprising: a pressurised aerosol canister including a vial containing a pharmaceutical formulation comprising an active ingredient, and a propellant, 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 the metering valve of the aerosol canister is received and axially located, the valve stem 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 cylindrical 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 cylindrical discharge orifice, wherein the actuator further comprises a delivery outlet for an aerosol plume, the cylindrical discharge orifice being arranged to direct the aerosol plume through the delivery outlet, wherein the nasal spray device is adapted to produce an aerosol plume for a dispensed dose having a spray force value no greater than 40 millinewtons (mN) measured at a distance of 30 millimeters (mm) from the cylindrical discharge orifice, wherein the cylindrical discharge orifice has a diameter of 0.15 to 0.65 mm and a length of 0.6 mm to 1.0 mm, and wherein the transfer channel has a length of 3 to 20 mm and has a transverse dimension in a range of 1.2 mm to 2 mm, the transverse dimension being measured at its maximum extent. 2. The nasal spray device of claim 1, wherein the transfer channel has a circular cross-section. 3. The nasal spray device of claim 1, wherein the transfer channel has a transverse dimension which tapers down towards an end of the cylindrical discharge orifice. 4. The nasal spray device of 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 cylindrical discharge orifice, the second part and the cylindrical discharge orifice being defined by a separate insert received into an opening formed in the stem block of the actuator. 5. The nasal spray device of claim 4, wherein an end of the insert is provided with a radial flange from which a resilient sleeve extends in a coaxial relationship with the second part of the transfer channel and the discharge orifice. 6. The nasal spray device of claim 5, wherein the resilient sleeve provides an interference fit in the opening and/or the insert is provided with a mechanical locking means for engagement with a corresponding means formed in the stem block. 7. The nasal spray device of claim 6, wherein the mechanical locking means comprises an annular flange and the corresponding means comprises a corresponding annular groove formed in a side wall of the opening, the annular flange being arranged to lock into the annular groove. 8. The nasal spray device of claim 1, wherein the pharmaceutical formulation further comprises a co-solvent present at 0.5 to 20% percentage by weight (w/w), based on a total weight of the pharmaceutical formulation. 9. The nasal spray device of claim 8, 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 anhydrous ethanol. 10. The nasal spray device of claim 8, wherein the co-solvent is ethanol or propylene glycol. 11. The nasal spray device of claim 8, wherein the co-solvent is present at 6 to 15% w/w based on a total weight of the pharmaceutical formulation. 12. A method of delivering a pharmaceutical formulation comprising: spraying metered doses of the pharmaceutical formulation into the nasal cavity via the nasal spray device of claim 1. 13. The nasal spray device of claim 1, wherein the pharmaceutical formulation is a solution formulation. 14. The nasal spray device of claim 1, wherein the pharmaceutical formulation is a suspension formulation. 15. The nasal spray device of claim 1, wherein the delivery outlet is a tubular nose piece adapted for insertion into a nostril. 16. The nasal spray device of claim 15, wherein the tubular nose piece has an inner diameter of 5 to 7.5 mm. 17. The nasal spray device of claim 1, wherein the discharge orifice has a diameter of 0. 20 to 0.50 mm. 18. The nasal spray device of claim 1, wherein the discharge orifice has a diameter of 0. 4 mm. 19. The nasal spray device of claim 1, wherein the transverse dimension of the transfer channel is 1.5 mm. 20. The nasal spray device of claim 1, wherein the transfer channel has a length of 4 mm to 15 mm. 21. The nasal spray device of claim 1, wherein the transfer channel has a length of 4 mm to 10 mm. 22. The nasal spray device of claim 1, wherein the delivery outlet, the discharge orifice and the transfer channel are aligned with each other. 23. The nasal spray device of claim 1, wherein the active ingredient is a steroid selected from beclomethasone dipropionate, budesonide, fluticasone propionate and mometasone furoate. 24. The nasal spray device of claim 1, wherein the active ingredient is beclomethasone dipropionate. 25. The nasal spray device of claim 1, wherein a delivered dose of the active ingredient of at least 50 .mu.g is provided. 26. The nasal spray device of claim 1, wherein the propellant is P134a and/or P227. 27. The nasal spray device of claim 1, wherein the propellant constitutes 80% w/w to 99% w/w based on a total weight of the pharmaceutical formulation. 28. The nasal spray device of claim 1, wherein the formulation comprises 0.02% to 0.6% w/w beclomethasone di propionate, 1% to 20% w/w ethanol and 80% to 99% w/w of propellant, wherein the percentages by weight are based on the total weight of the aerosol. 29. The nasal spray device of claim 1, wherein the discharge orifice has a diameter of 0.22 or 0.4 mm and a length of 0.65 mm, wherein the transfer channel has a length of 5 or 10 mm, and wherein the pharmaceutical formulation comprises beclomethasone dipropionate as active ingredient, P134a as propellant and ethanol as co-solvent. 30. The nasal spray device of claim 1, wherein the discharge orifice has a diameter of 0.4 mm, wherein the transfer channel has a length of 10 mm, wherein the delivery outlet has an inner diameter of 8.2 mm, and wherein the pharmaceutical formulation comprises beclomethasone dipropionate as active ingredient, P134a as propellant and ethanol as co-solvent.