Nasal Delivery Devices

Abstract

A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a container-receiving unit comprising a container chamber for receiving a substance-containing container which contains substance to be delivered to the nasal cavity of the subject, the container chamber including an inlet and an outlet; a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject and being in fluid communication with the outlet of the container chamber; a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the container chamber and through which the subject in use exhales, such as to entrain substance from the container and deliver the same through the nosepiece; and moisture-mitigation means for mitigating an effect of moisture in an exhaled breath on the entrainment of substance from the container, which means are provided, for example, by providing the container in a replaceable container-containing member, by a pressure-sensitive valve which normally closes the fluid connection between the container chamber and the mouthpiece, and a temperature regulator upstream of the container chamber.

Description

[0001]The present invention relates to nasal delivery devices and methods for delivering substances, in particular particulate substances, such as powdered substances, to the nasal cavities of subjects, and in particular multi-dose devices adapted for use with a plurality of containers, such as capsules, blisters and vials, which each contain a single dose of substance.BACKGROUND OF THE INVENTION[0002]Current nasal delivery systems can adequately treat topical diseases, but are not suited to the delivery of substances to the upper part of the nasal airway, and in particular for targeted delivery to the olfactory region and sinus ostia.[0003]The Turbohaler® as developed by AstraZeneca AB, where adapted for nasal delivery has not been a success. A large fraction of particles is deposited in the anterior region of the nasal cavity. Furthermore, the nasal cavity becomes narrower during nasal inhalation, thus further reducing the deposition efficiency in the posterior regions of the nasa...

AI Technical Summary

Benefits of technology

[0006]In another embodiment it is an aim of the present invention to prevent delivery to selected regions of the nasal cavity, in particular to the anterior valve area, by utilizing two separate delivery channels, that is, a central channel for the drug substance and air, and an outer channel which acts to modify and optimize the deposition pattern of the particles in the nasal cavity.

[0007]In one aspect the present invention provides a nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising: a container-receiving unit comprising a container chamber for receiving a substance-containing container which contains substance to be delivered to the nasal cavity of the subject, the container chamber including an inlet and an outlet; a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject and being in fluid communication with the outlet of the container chamber; a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the container chamber and through which the subject in use exhales, such as to entrain substance from the container and deliver the same through the nosepiece; and moisture mitigation means for mitigating an effect of moisture in an exhaled breath on the entrainment of substance from the container, which means are provided, for example, by providing the container in a replaceable container-containing member, by a pressure-sensitive valve which normally closes the fluid connection between the container chamber and the mouthpiece, and a temperature regulator upstream of the container chamber.

[0011]In a still further aspect the present invention provides a method of delivering substance to a nasal cavity of a subject, the method comprising the steps of: disposing a substance-containing container which contains substance to be delivered to the nasal cavity of the subject in a container chamber, the container chamber including an inlet and an outlet; fitting a nosepiece in fluid communication with the outlet of the container chamber to a nasal cavity of the subject; the subject exhaling through a mouthpiece which is in fluid communication with the inlet of the container chamber, such as to deliver an air flow through the container chamber and entrain substance from the container and deliver the same through the nosepiece and into the nasal cavity of the subject; and drawing moisture from the exhaled air flow upstream of the container chamber, such as to reduce condensation at or downstream of the container chamber.

Problems solved by technology

Current nasal delivery systems can adequately treat topical diseases, but are not suited to the delivery of substances to the upper part of the nasal airway, and in particular for targeted delivery to the olfactory region and sinus ostia.

The Turbohaler® as developed by AstraZeneca AB, where adapted for nasal delivery has not been a success.

Furthermore, the nasal cavity becomes narrower during nasal inhalation, thus further reducing the deposition efficiency in the posterior regions of the nasal airway, in particular in narrow and congested noses.

There is also a considerable risk of inhalation of small particles to the lungs, as demonstrated in previous studies.

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