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.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This patent application claims priority to U.S. Provisional Patent Application No. 61 / 392,223, filed Oct. 12, 2010, which is incorporated by reference herein.FIELD OF THE INVENTION[0002]This invention relates to a nasal spray device and particularly to a nasal spray device for the delivery of a pharmaceutical formulation to the nasal cavity in metered doses.BACKGROUND OF THE INVENTION[0003]Nasal spray devices for the delivery of medicament to the nasal cavity, particularly the nasal mucosa, can be useful for the prophylaxis and / or treatment of certain diseases and disorders of the nasal cavity. Such devices are also capable of delivering medicament to the systemic circulation via the turbinates and lymphoid tissues located at the back of the nasal cavity and to the central nervous system via the olfactory region at the top of the nasal cavity.[0004]Nasal spray devices include unit-dose (single use) devices having syringe-like mechanisms an...

AI Technical Summary

Benefits of technology

[0013]It has now surprisingly been found that even formulations containing high levels of co-solvent are well tolerated in a nasal spray formulation, provided the nasal spray device used to deliver the formulation to the nasal cavity is adapted to provide a so-called “soft spray”. The nasal spray device having the propellant-based formulation described hereinbelow provides the advantages of a metered dose pressurised aerosol canister without suffering from the disadvantage of poor patient tolerability.

Problems solved by technology

Although nasal spray devices having manually operated pumps have achieved some success in the marketplace, they have a number of drawbacks.

For example, manually operated pumps have a relatively large actuation force which may, for some users, such as the very young and the elderly, be difficult to achieve on a repeatable basis.

Moreover, variations in the applied actuation force can lead to some users receiving medicament doses with less than optimal spray characteristics.

However, whereas pressurised metered dose inhalers (MDIs) have found broad market acceptance in devices intended for the pulmonary administration of medicaments by inhalation via the mouth into the lungs, MDIs have not found applications in nasal spray devices.

It has generally been considered that nasal spray formulations cannot tolerate the excipients found in pMDI formulations.

In particular, the high levels of co-solvents, such as ethanol, found in solution formulations are poorly tolerated by patients on account of the unpleasant sensation which they produce in the nasal cavity on administration.

There is a mention that the formulation may be administered nasally; however, there is no disclosure of how this method of administration can be achieved and there is no consideration of the problem of poor patient tolerability for nasal applications.

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