US 7,799,337 B2Granted

Method for directed intranasal administration of a composition

OwnerBruce H. Levininventor

Life of this patent

Estimating the term…

Loading patent…

Abstract

Methods, kits, apparatus, and compositions for inhibiting a cerebral neurovascular disorder, a muscular headache, or cerebral inflammation in a human patient are provided. The methods comprise intranasally administering to the patient a pharmaceutical composition comprising a local anesthetic, and preferably a long-acting local anesthetic ingredient. A composition useful for practicing the methods of the invention is described which comprises at least one local anesthetic in a pharmaceutically acceptable carrier, wherein the composition is formulated for intranasal delivery. Cerebral neurovascular disorders include migraine and cluster headache. Muscular headaches include tension headaches and muscle contraction headaches. A kit comprising the composition and an intranasal applicator and a method of systemically delivering a pharmaceutically active agent to an animal are also included in the invention. Apparatus for directed intranasal administration of the compositions of the invention and for performing the methods of the invention are also described.

Claims23

Dependent claims

A method of intranasally administering a composition directly to a selected intranasal location of a human patient other than for effecting a block of the sphenopalatine ganglion, the method comprising

providing a composition comprising a pharmaceutically active agent which is a pharmaceutically active agent other than a local anesthetic or which is a pharmaceutically active agent in combination with a local anesthetic, wherein the composition does not have only a local anesthetic as the only pharmaceutically active agent,
inserting into a nostril of the patient an intranasal delivery device comprising a preformed body having a proximal end and a distal portion having a distal end, wherein the distal portion of the delivery device is curved or angled with respect to a longitudinal axis of the body, the longitudinal axis of the body at the distal end forming an angle of about 90 degrees to about 170 degrees with respect to the longitudinal axis at the proximal end prior to insertion of the distal end into a nasal cavity,
urging the delivery device through the nostril such that the distal end is directed to the selected intranasal location, and
directing the administration of the composition directly to the selected intranasal location via the delivery device by one of
contacting the selected intranasal location by the composition on at least a portion of the distal end of the delivery device and
by delivering the composition through at least one outlet port at the distal portion of the delivery device to which the composition is delivered through a lumen extending through the body to the selected intranasal location for causing the composition to selectively enter at least one of (i) the inferior boundary of the nasopharynx, (ii) sinuses via pathways specific thereto, and (iii) cerebral tissue selected from the group consisting of cerebral spinal fluid, a cerebral neuronal structure and cerebral vasculature, via pathways specific thereto.

3 more elements

(a) providing a composition comprising a pharmaceutically active agent which is a pharmaceutically active agent other than a local anesthetic or which is a pharmaceutically active agent in combination with a local anesthetic, wherein the composition does not have only a local anesthetic as the only pharmaceutically active agent,
(b) seating within the nasal cavity of the patient an anatomically adapted intranasal delivery nozzle, the nozzle comprising a preformed body having
a delivery lumen extending therethrough from a proximal end of the body to an outlet port at a distal portion of the body, and
an exterior portion having
(i) a flattened portion extending situated peripherally between the proximal end and the distal portion and extending substantially from the proximal end to the distal portion, for seating the nozzle against the nasal septum of the patient,
(ii) an anterior portion situated peripherally between the proximal end and the distal portion for seating the nozzle against a portion of the nasal cartilage of the patient, and
(iii) an indented portion situated peripherally between the proximal end and the distal portion for seating the nozzle against a nasal concha of the patient, wherein when the nozzle is seated, the outlet port is situated within the nasal cavity of the patient such that the axis extending through the discharge port is offset from the apex of the nasal cavity by no more than about 30 degrees, and thereafter
(c) providing the composition to the delivery lumen, whereby the composition is intranasally administered in a directed manner to the selected intranasal location for causing the composition to selectively enter at least one of (i) the inferior boundary of the nasopharynx, (ii) sinuses via pathways specific thereto, and (iii) cerebral tissue selected from the group consisting of cerebral spinal fluid, a cerebral neuronal structure and cerebral vasculature, via pathways specific thereto.

5 more elements

Dependencies are inferred from the claim text.

Facts

Application: 10/218,138Filed 12 Aug 2002 · continuation in part
Priority: 21 Jul 1997
Published: US 2003/0133877 A117 Jul 2003
Granted: 21 Sep 2010
Term ends: Not estimatedThe source records don’t support an estimate.

Classification19 codes

A61N 1/0551
For implantation or insertion into the body, e.g. heart electrode: spinal or peripheral nerve electrodes
A61K 9/0043
Galenical forms characterised by the site of application: nose
A61K 31/00
Medicinal preparations containing organic active ingredients
A61K 31/167
Having aromatic rings, e.g. colchicine, atenolol, progabide: having the nitrogen of a carboxamide group directly attached to the aromatic ring,…

Family

Application60/090,110Us provisional application · filed 21 Jul 1997
Application60/072,845Us provisional application · filed 28 Jan 1998
Application60/084,559Us provisional application · filed 6 May 1998
Application09/118,615Parent of this continuation-in-part · filed 17 Jul 1998
Application60/117,398Us provisional application · filed 27 Jan 1999
Application60/170,817Us provisional application · filed 15 Dec 1999
Application09/492,946Parent of this continuation-in-part · filed 27 Jan 2000
Application09/737,302Parent of this continuation-in-part · filed 15 Dec 2000
US 2003/0133877 A1Pre-grant publication · published 17 Jul 2003
US 6,491,940 B1Parent of this continuation-in-part
US 6,432,986 B1Parent of this continuation-in-part
US 2001/0004644 A1Published application
US 2001/0055607 A1Published application
US 7,799,337 B2This patent

From the US filing history. Foreign family members aren’t listed.