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Nasal administration

a technology of nasal administration and substances, applied in the direction of respirators, cell components, electrochemical generators, etc., can solve problems such as unwanted effects, and achieve the effects of increasing the delivery of substances, increasing the uptake of substances into the cns, and increasing the cns

Inactive Publication Date: 2014-05-29
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention provides a delivery system for nasal administration that targets the posterior region of the nasal airway, particularly the upper posterior region, which results in a greater uptake of substance into the central nervous system (CNS) compared to the frontal region. This may explain the disproportionate effect of nasal administration compared to other methods of drug administration, such as injection or oral. The nasal route of administration offers advantages such as ease of administration, rapid onset, and patient control, and is also suitable for patients who have difficulty in taking oral medication.

Problems solved by technology

However, high blood plasma concentrations can cause unwanted effects, notably, systemic side effects.
This may be particularly problematic in systems which require a rapid onset of action, as such systems rely on achieving high blood plasma concentrations in order to create a significant driving gradient for the rapid uptake of drug into the CNS.

Method used

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  • Nasal administration
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Examples

Experimental program
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Effect test

example # 1

Example #1

[0168]The purpose of this study was to determine the relative sedative effect of midazolam where intranasally delivered using the novel, bi-directional administration system of the present applicant.

[0169]In this study, twelve healthy subjects, 4 male and 8 female, were studied. In separate sessions, the subjects received 3.4 mg of midazolam by one of three different administration systems, these being: an intravenous administration system in which a midazolam formulation was intravenously administered; conventional nasal spray administration system in which a midazolam formulation was conventionally nasally administered using a spray pump as supplied by 1 ng Erich Pfeiffer GmbH (Radolfsee, Germany) which is specified to generate a liquid spray with a mean particle size of 43 μm, with 100 μl of the formulation being delivered to each nostril; and the bi-directional administration system of the first-described embodiment, and incorporating the same spray pump as the convent...

example # 2

Example #2

[0190]This study provides for characterization of the deposition as achieved by the nasal administration systems of the above-described study.

[0191]In this study, nine healthy subjects, 4 females and 5 males, were studied.

[0192]In separate sessions, the subjects received a test solution by one of two different nasal administration systems, these corresponding to the nasal administration systems of the above study and being:[0193](i) a conventional nasal spray administration system in which a labeled test solution was conventionally nasally administered using a spray pump as supplied by 1 ng Erich Pfeiffer GmbH (Radolfsee, Germany) which is specified to generate a liquid spray with a mean particle size of 43 μm, with 100 μl of the test solution being delivered to one nostril; and[0194](ii) the bi-directional administration system of the first-described embodiment, and incorporating the same spray pump as the conventional nasal spray administration system, in which a labeled...

example # 3

Example #3

[0209]The purpose of this study was to characterize the deposition as achieved by powder aerosol and liquid jet administration systems in accordance with embodiments of the present invention.

[0210]In this study, nine healthy subjects, 4 females and 5 males, were studied.

[0211]In separate sessions, the subjects received a test substance by one of three different nasal administration systems, these being:[0212](i) a conventional nasal spray administration system in which a labeled test solution was conventionally nasally administered using a single-dose spray pump as supplied by 1 ng Erich Pfeiffer GmbH (Radolfsee, Germany) which is specified to generate a liquid spray with a mean particle size of 43 μm, with 100 μl of the test solution being delivered to one nostril;[0213](ii) the bi-directional administration system of the first-described embodiment where configured to deliver a labeled test powder from a conventional gelatine capsule, with approximately 4 mg of the test p...

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Abstract

A delivery device for and method of providing for delivery of substance to the central nervous system (CNS) of a subject, the delivery device comprising: a nosepiece unit for insertion into a nasal airway of a subject and comprising an outlet unit which includes a nozzle for delivering substance into the nasal airway of the subject; and a substance supply unit which is operable to deliver a dose of substance to the nozzle; wherein the delivery device is configured such that at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the nasal airway, thereby providing a CNS concentration of the substance, and hence CNS effect, which is significantly greater than that which would be predicted from a counterpart blood plasma concentration of the substance.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation of U.S. patent application Ser. No. 2 / 161,466, filed on Feb. 1, 2011, which is a U.S. National phase application of PCT / GB2006 / 000182 filed Jan. 19, 2006, the disclosure of which applications are incorporated herein by reference.FIELD OF INVENTION[0002]The present invention relates to the nasal administration of substances, in particular drugs, to the central nervous system (CNS) via the nasal airway.BACKGROUND[0003]Referring to FIG. 1(a), the nasal airway 1 comprises the two nasal cavities separated by the nasal septum, which airway 1 includes numerous ostia, such as the paranasal sinus ostia 3 and the tubal ostia 5, and olfactory cells, and is lined by the nasal mucosa. The nasal airway 1 can communicate with the nasopharynx 7, the oral cavity 9 and the lower airway 11, with the nasal airway 1 being in selective communication with the anterior region of the nasopharynx 7 and the oral cavity 9 by openin...

Claims

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Application Information

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IPC IPC(8): A61M15/08A61M15/00A61K31/404
CPCA61K31/404A61M11/00A61M15/0065A61M15/009A61M15/08A61M2202/04A61M2202/064A61M15/0021A61M15/0098A61M16/0493H01M4/861H01M4/8642H01M4/8657H01M4/9066H01M8/023H01M8/0247H01M2004/8684H01M2008/1293Y02E60/50A61M15/0091A61M16/20A61M16/049
Inventor DJUPESLAND, PER GISLEHAFNER, PETER RODERICK
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