NASAL ADMINISTRATION

• US 20140144442A1
• Filed: 01/29/2014
• Published: 05/29/2014
• Est. Priority Date: 01/19/2006
• Status: Abandoned Application

• Current Assignee: OptiNose AS (OptiNose, Inc.)
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Hafner, Peter Roderick
• Application Number:
  US14/167,928
• Publication Number:
  US 20140144442A1
• Time in Patent Office: Days
• US Class Current: 128/203.15
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/049 Mouthpieces
• CPC Class Codes: A61M 16/0493 with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: H01M 2004/8684 Negative electrodes
• CPC Class Codes: H01M 2008/1293 Fuel cells with solid oxide electrolytes
• CPC Class Codes: H01M 4/861 with a gradient in the porosity
• CPC Class Codes: H01M 4/8642 Gradient in composition
• CPC Class Codes: H01M 4/8657 layered
• CPC Class Codes: H01M 4/9066 of metal-ceramic composites or mixtures, e.g. cermets
• CPC Class Codes: H01M 8/023 Porous and characterised by the material
• CPC Class Codes: H01M 8/0247 : characterised by the form characterised by a channel configuration H01M8/0258
• CPC Class Codes: Y02E 60/50 : Fuel cells

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.

Claims

1. A delivery device for 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 which is posterior of the nasal valve and above the inferior meatus, and thereby provides a CNS effect which is significantly greater than that predicted from a counterpart blood plasma concentration of the substance;

wherein the substance comprises sumatriptan or its pharmaceutically-acceptable derivatives or analogues.

2. The delivery device of claim 1, wherein the nozzle is configured to deliver a powder aerosol.

3. The delivery device of claim 1, further comprising:

a mouthpiece through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject.

4. The delivery device of claim 3, wherein the outlet unit further comprises a delivery channel which is fluidly connected to the mouthpiece, whereby exhaled air from an exhalation breath of the subject is delivered through the nosepiece unit into the nasal airway of the subject.

5. The delivery device of claim 1, wherein the substance supply unit is breath actuated.

6. The delivery device of claim 1, wherein the delivery device is configured such that at least 40% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region of the nasal airway.

7. The delivery device of claim 1, wherein the delivery device is configured such that at least 50% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region of the nasal airway.

8. The delivery device of claim 1, wherein the outlet unit includes no cuff member which obstructs a region of the nasal airway which is anterior of the nasal valve.

9. The delivery device of claim 1, wherein the ratio of the peak CNS effect to the peak blood plasma concentration is at least 2 times that achieved using intravenous (IV) delivery.

10. The delivery device of claim 1, wherein the ratio of the peak CNS effect to the peak blood plasma concentration is at least 3 times that achieved using intravenous (IV) delivery.

11. The delivery device of claim 1, wherein the substance is for the treatment of a condition which requires a rapid onset of action in order to ameliorate or abort a CNS event.

12. The delivery device of claim 1, wherein the substance is for the treatment of migraine.