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Nasal Delivery Devices

a nasal mucosa and nasal tube technology, applied in the field of nasal tube delivery devices, can solve the problems of significant obstacles to reliable and cost-effective delivery, snoring and sleep disturbance, and the effect of liver effect is significant, so as to reduce the chance of inhalation of the substance, prevent the effect of inhalation and low production cos

Inactive Publication Date: 2008-09-18
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]Medicaments can also be systemically delivered through the nasal pathway, the nasal pathway offering a good administration route for the systemic delivery of pharmaceuticals, such as hormones, for example, oxytocin and calcitionin, and analgetics, such as anti-migraine compositions, as the high blood flow and large surface area of the nasal mucosa advantageously provides for rapid systemic uptake.
[0029]Furthermore, the nose geometry is designed to humidify, warm and filter the inspired air to protect the lower airways. The resistance in the nose alone equals 50% of the total airway resistance, and the resistance may increase immensely when congested. Owing to the high anterior resistance, turbulence occurs just posterior to the constriction, increasing deposition in this region. To achieve a better distribution to larger and more posterior parts of the nasal mucosa, it is envisaged to be advantageous to have the drug released at a lower flow in a congested nose and at a higher flow in an open nose. This requires a system which can be released not only by flow, but also by pressure. Such release is essential for efficient and reliable exhalation-triggered nasal drug delivery. The two main triggering modes, flow and pressure, are to certain extent overlapping. They can be incorporated in one single mechanism or provided as separate mechanisms. However, the nose may become completely blocked, in particular during colds and allergic attacks. In this situation, it becomes impossible to establish a bi-directional air flow, but still it is desirable and necessary to deliver drugs to the nose.

Problems solved by technology

As will be understood, nasal congestion impedes nasal breathing and promotes oral breathing, leading to snoring and sleep disturbance.
For such substances, the metabolism in the intestines and the first-pass-effect in the liver represent significant obstacles for reliable and cost-efficiency delivery.
Whilst the provision of a spray having a larger mean particle size prevents the inhalation of the particles, these larger particles are not optimal for achieving a good distribution to the nasal mucosa.
Such operation requires a relatively high actuation force, typically of the order of 50 N, which high force often leads to significant movement of the delivery device, it being very difficult to maintain a delivery device stationary when attempting to apply a high actuation force.
Movement of the delivery device, both in the positioning and orientation of the nozzle, will lead to poor reproducibility, dose accuracy and patient compliance.
One drawback with traditional pMDIs is that the subject must co-ordinate inhalation with the aerosol release in order to deliver the aerosolized medicament effectively to the lower airway.
Inadequate co-ordination represents a considerable problem, significantly reducing both lung deposition and reproducibility.
Another drawback with traditional pMDIs is the use of chlorine-containing compounds as the propellant gas, as such gases are not environmentally friendly and have been demonstrated to destroy the ozone layer.
Increased airway resistance in pathological conditions, both in the pulmonary and nasal airways, is a challenge.
Furthermore, the releasing action should require as little energy as possible, as any resistance in the device will impede free inhalation.
However, the nose may become completely blocked, in particular during colds and allergic attacks.

Method used

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Examples

Experimental program
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first embodiment

[0083]FIGS. 2(a) to (d) illustrate an oral exhalation breath-actuated nasal delivery device in accordance with the present invention.

[0084]The delivery device comprises a housing 32 which includes a chamber 34 for receiving the exhalation breath of a subject, a nosepiece 40 for fitting in a nostril of the subject which is in fluid communication with the chamber 34 in the housing 32 and disposed to one, the distal, end of the housing 32, and a mouthpiece 42 through which the subject exhales and which is in fluid communication with the chamber 34 in the housing 32.

[0085]The nosepiece 40 is an expandable member which is configured to expand on exhalation through the mouthpiece 42 such as to promote a sealing fit between the nosepiece 40 and a nostril of a subject, with such a sealing fit only being achievable on the nosepiece 40 firstly being sufficiently inserted into the nostril of the subject for effective operation of the delivery device. Where the nosepiece 40 is not sufficiently ...

second embodiment

[0098]FIGS. 3(a) to (d) illustrate an oral exhalation breath-actuated nasal delivery device in accordance with the present invention.

[0099]The delivery device of this embodiment is very similar to the delivery device of the above-described first embodiment, and thus, in order to avoid unnecessary duplication of description, only the differences will be described in detail, with like reference signs designating like parts.

[0100]The delivery device of this embodiment differs from that of the above-described first embodiment in further comprising an oral exhalation breath-actuatable gas supply unit 98 for delivering a gas flow to the chamber 34 in the housing 32 in response to exhalation by a subject, and in that the mouthpiece 42 is in fluid communication with the gas supply unit 98 and not the chamber 34 in the housing 32, whereby a controlled gas flow is delivered to the chamber 34 in the housing 32, and hence the nasal airway of a subject, from the gas supply unit 98 in response to...

third embodiment

[0102]FIG. 4 illustrates an oral exhalation breath-actuated nasal delivery device in accordance with the present invention.

[0103]The delivery device comprises a nosepiece 101 for fitting in one nostril of a subject to provide a fluid-tight seal therewith, a mouthpiece 103 through which the subject exhales, and a flow channel 105 which fluidly connects the nosepiece 101 and the mouthpiece 103. With this configuration, exhaled air from an exhalation breath of a subject is delivered through the nasal airway of the subject.

[0104]In this embodiment the delivery device further comprises a filter unit 107 which is disposed at the inlet end of the flow channel 105, here including a moisture filter. In a preferred embodiment the filter unit 107 could include an anti-microbial filter.

[0105]The delivery device further comprises a pressure detector 109, in this embodiment an electronic pressure detector, which is disposed in the flow channel 105, in this embodiment downstream of the filter unit...

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Abstract

An exhalation breath-actuated nasal delivery device for and a method of delivering a substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece (40) for fitting to a nostril of a subject; a mouthpiece (42) through which the subject in use exhales; and delivery unit (64), as one of a mechanical delivery pump (66) or a nebulizer (115), for delivering a substance to the nosepiece (40); and an actuation mechanism (74) for actuating the delivery unit in response to oral exhalation through the mouthpiece, and preferably when at least one or both of the pressure at or the flow rate through the nosepiece exceeds a predetermined threshold.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 10 / 469,114 filed Feb. 12, 2004, which is a national phase of International Application No. PCT / IB02 / 001612 filed Feb. 26, 2002 and published in the English language, which claims priority to GB patent application no. 0104692.9 filed on Feb. 26, 2001, and a continuation-in part of U.S. patent application Ser. No. 09 / 700,532 filed Nov. 15, 2000, each of which is incorporated herein by reference.FIELD OF INVENTION[0002]The present invention relates to a nasal delivery device for and a method of delivering a substance, in particular one of a liquid, as a suspension or solution, or a powder containing a medicament, especially systemic or topical pharmaceuticals, a cleansing agent, or an irrigating agent, as a liquid, preferably combined with a cleansing agent, to the nasal airway of a subject. In particular, the present invention relates to an oral exhalation breath-actuate...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M11/00A61B5/085A61B5/097A61M15/00A61M15/08A61M16/00
CPCA61B5/085A61M15/0098A61B5/415A61B5/4839A61M11/005A61M15/0065A61M15/009A61M15/0091A61M15/08A61M2016/0021A61M2202/064A61M2205/071A61M2205/073A61M2205/13A61M2210/0668A61M2230/43A61M11/02A61M11/007A61B5/097A61M11/001A61M11/006A61M15/002A61M15/0021A61M2202/04
Inventor DJUPESLAND, PER GISLE
Owner OPTINOSE AS
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