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Nasal spray device

a spray device and spray tube technology, applied in the direction of aerosol delivery, immunologic disorders, drug compositions, etc., can solve the problems of difficult repeatability, large actuation force of manual pumps, young and elderly,

Inactive Publication Date: 2012-04-12
TEVA BRANDED PHARMA PROD R & D +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a nasal spray device for delivering pharmaceutical formulations to the nasal cavity in metered doses. The device includes a pressurized aerosol canister with a valve stem and an actuator for the canister. The actuator includes a stem block with a receptacle for the valve stem and a discharge orifice for the pharmaceutical formulation. The device produces an aerosol plume with a spray force value no greater than 40 mN measured at a distance of 30 mm from the discharge orifice. The device is well tolerated even with formulations containing high levels of co-solvent. The advantages of a metered dose pressurized aerosol canister are provided without 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.

Method used

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Examples

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example 1

[0052]Spray force values for a nasal spray device according to the present invention were measured using a variety of actuation velocities and accelerations. The device tested was of the type shown in FIGS. 1 and 3 and configured with a nose piece having an inner diameter of 8.2 mm. The stem block insert had the shape generally shown in FIG. 4. The orifice size is 0.4 mm and insert length is 10 mm. The device was loaded with a HFA aerosol canister configured to provide an 80 μg dose (ex-valve) of beclomethasone dipropionate. The solution formulation consisted of the beclomethasone dipropionate as the active ingredient, together with ethanol 4.8 mg per actuation as a co-solvent and P134a 55.1 mg per actuation as a propellant. Spray force values for three commercially available manual pump-type nasal spray devices were also measured using the same variety of actuation velocities and accelerations for comparison purposes. Details of the devices tested are summarised in Table 1.

TABLE 1D...

examples 2-5

[0081]Further testing was carried out on the test devices of the type shown in FIGS. 1 and 3 having different stem block inserts. The devices were each configured with a nose piece having an inner diameter of 7.2 mm. The stem block insert of each device had the shape generally shown in FIG. 4, with the dimensions provided in Table 6. The orifice size is 0.4 mm, the insert length of 10 mm, a land length of 0.65 mm, and a tip diameter of 6.4 mm. The device was loaded with an HFA aerosol canister configured to provide a 100 μg dose (ex-valve) of beclomethasone dipropionate. The solution formulation consisted of the beclomethasone dipropionate as the active ingredient, together with ethanol 4.8 mg per actuation as a co-solvent and P134a 55.1 mg per actuation as a propellant.

TABLE 6DevicesDischarge orificeInsertExample no.diameter (mm)length (mm)Example 20.225Example 30.2210Example 40.45Example 50.410Comparative Example 40.75Comparative Example 50.710

[0082]The nasal spray devices were te...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M11/04A61P37/08A61P29/00A61K9/12
CPCA61M15/009B65D83/54A61M15/08A61K31/57A61M15/0028A61M31/00A61P29/00A61P37/08A61K9/0043
Inventor ZENG, XIAN-MINGWALSH, DECLANLY, JADE CHING-YINGMORALES, ARMANDO
Owner TEVA BRANDED PHARMA PROD R & D
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