Granted Patent
B2
US 12,616,807 · App. 18/669,046 · Granted May 5, 2026
Medical counter measures including dry powder formulations and associated methods
Assignee:
Belhaven BioPharma Inc.
A61M15/08A61K9/0043A61K9/1611A61K9/1623A61K9/1652A61K31/13A61K31/137A61K31/277A61K31/417A61K31/4425A61K31/46A61K31/55A61K31/5513A61M2205/3327A61M2209/06
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Abstract
Provided herein are dry powder formulations comprising at least one active pharmaceutical ingredient suitable for nasal application. Also provided are unit dose forms and devices comprising such formulations and methods of using such formulations for the treatment of various conditions including respiratory conditions, hemodynamic collapse, seizures, migraines, and other conditions.
Claims (40)
1 . A device for intranasal administration of a pharmaceutical composition comprising:
a reservoir and a means for discharging one or more doses of the pharmaceutical composition, wherein the reservoir contains a quantity of the pharmaceutical composition;
wherein the pharmaceutical composition is a dry powder comprising:
galantamine or a pharmaceutical salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 75 mg of the galantamine or the pharmaceutical salt thereof;
sodium chloride, wherein the pharmaceutical composition comprises about 0.01 mg to about 5 mg of the sodium chloride; and
a carrier;
wherein the pharmaceutical composition does not include chitosan.
2 . The device of claim 1 , wherein the device includes a nasal probe, and wherein the nasal probe is constructed and configured to be replaced between discharges.
3 . The device of claim 1 , wherein the pharmaceutical composition further comprises a vasoactive agent, wherein the vasoactive agent is epinephrine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.01 mg to about 10 mg of the epinephrine or the pharmaceutically acceptable salt thereof.
4 . The device of claim 1 , wherein the pharmaceutical composition further comprises an anti-convulsant agent, wherein the anti-convulsant agent is diazepam or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.1 mg to about 20 mg of the diazepam or the pharmaceutically acceptable salt thereof.
5 . The device of claim 1 , wherein the pharmaceutical composition further comprises at least one anticholinergic agent, wherein the at least one anticholinergic agent is atropine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.1 mg to about 10 mg of the atropine or the pharmaceutically acceptable salt thereof.
6 . The device of claim 1 , wherein the pharmaceutical composition further comprises a cholinesterase reactivator, wherein the cholinesterase reactivator is 2-pyridine aldoxime methyl chloride or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 1 mg to about 1000 mg of the pyridine aldoxime methyl chloride or the pharmaceutically acceptable salt thereof.
7 . The device of claim 1 , wherein the pharmaceutical composition further comprises a vasodilator, wherein the vasodilator is phentolamine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.01 mg to about 10 mg of the phentolamine or the pharmaceutically acceptable salt thereof.
8 . The device of claim 1 , wherein the pharmaceutical composition further comprises a catechol-o-methyl transferase (COMT) inhibitor, wherein the COMT inhibitor is entacapone or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 20 mg of the entacapone or the pharmaceutically acceptable salt thereof.
9 . The device of claim 1 , wherein the pharmaceutical composition further comprises an N-Methyl-D-aspartate (NMDA) receptor antagonist, wherein the NMDA receptor antagonist is memantine, wherein the pharmaceutical composition provides a dose of about 1 mg to about 40 mg of the memantine.
10 . The device of claim 1 , wherein the pharmaceutical composition further comprises a chelator.
11 . The device of claim 1 , wherein the pharmaceutical composition further comprises one or more agents selected from a group consisting of a mucosal permeation or penetration enhancer, a mucoadhesive, a mucosal transit slowing agent, a mucosal transport enhancer, or any combination thereof.
12 . The device of claim 1 , wherein the device has 360° functionality and is constructed and configured to dispense a dose from any position.
13 . The device of claim 1 , wherein the pharmaceutical composition is a spray-dried powder.
14 . The device of claim 1 , wherein the device further includes a sensor that is adapted to detect a displacement or a deformation of a portion of the delivery device when the dose is dispensed.
15 . The device of claim 1 , wherein the device further includes a display, a power supply, a timer, a clock, and/or a printed circuit board, wherein the display is constructed and configured to display a time of dose dispensation.
16 . The device of claim 1 , wherein the device further includes a communications interface, wherein the communications interface is constructed and configured to transmit data wirelessly to at least one remote device.
17 . A kit for intranasal administration of a pharmaceutical composition comprising:
at least one device, wherein each of the at least one device includes a reservoir and a means for discharging one or more doses of the pharmaceutical composition, wherein the reservoir contains a quantity of the pharmaceutical composition; and
a pouch and/or a hard case;
wherein the pharmaceutical composition is a dry powder comprising:
galantamine or a pharmaceutical salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 75 mg of the galantamine or the pharmaceutical salt thereof;
sodium chloride, wherein the pharmaceutical composition comprises about 0.01 mg to about 5 mg of the sodium chloride; and
a carrier;
wherein the pharmaceutical composition does not include chitosan.
18 . The kit of claim 17 , wherein the hard case includes a desiccant plastic, wherein the desiccant plastic includes a base polymer, a channeling agent, and a desiccant.
19 . The kit of claim 17 , wherein the pouch and/or the hard case incorporates a pouch attachment ladder system (PALS).
20 . A device for intranasal administration of a pharmaceutical composition comprising:
a reservoir and a means for discharging one or more doses of the pharmaceutical composition, wherein the reservoir contains a quantity of the pharmaceutical composition;
wherein the pharmaceutical composition is a dry powder comprising:
galantamine or a pharmaceutical salt thereof, wherein the pharmaceutical composition provides a dose of the galantamine or the pharmaceutical salt thereof;
memantine, wherein the pharmaceutical composition provides a dose of about 1 mg to about 30 mg of the memantine;
sodium chloride, wherein the pharmaceutical composition comprises about 0.01 mg to about 5 mg of the sodium chloride; and
a carrier;
wherein the pharmaceutical composition does not include chitosan.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 21, 2024
From: LYMAN, SCOTT; BLESKE, BARRY
To: BELHAVEN BIOPHARMA INC.
Reel/Frame 067475/0017 →
Continuity (3)
Provisional Application
63290948
· Dec 17, 2021
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