Granted Patent
B2
US 12,678,404 · App. 18/883,447 · Granted Jul 14, 2026
Dry powder formulations of epinephrine and associated methods
Inventors:
Scott Lyman (Raleigh, NC); Barry Bleske (Albuquerque, NM); Ted William Lanpher (Half Moon Bay, CA)
Assignee:
Belhaven BioPharma Inc.
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Abstract
Provided herein are dry powder formulations comprising epinephrine alone or in combination with at least one enabling agent 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 anaphylaxis, anaphylactoid reaction, respiratory conditions, hemodynamic collapse, and for administration during cardiopulmonary arrest and other life-threatening conditions.
Claims (18)
1 . A dry powder pharmaceutical composition comprising:
a sole active ingredient, wherein the sole active ingredient consists of epinephrine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 2.0 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof;
a citrate; and
a carrier;
wherein the pharmaceutical composition has a moisture content of between about 3% and about 6%.
2 . The dry powder pharmaceutical composition of claim 1 , wherein a median particle diameter of the epinephrine or the pharmaceutically acceptable salt thereof is about 20 μm to about 75 μm.
3 . The dry powder pharmaceutical composition of claim 1 , wherein the carrier includes mannitol, a cyclodextrin, citric acid, lactose, and/or sodium carboxymethylcellulose.
4 . The dry powder pharmaceutical composition of claim 1 , wherein the quantity of the pharmaceutical composition is between about 5 mg and about 75 mg.
5 . A dry powder pharmaceutical composition comprising:
a sole active ingredient, wherein the sole active ingredient consists of epinephrine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 2.0 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof;
a citrate;
a carrier;
wherein the pharmaceutical composition does not include an alpha-adrenergic blocker;
wherein the pharmaceutical composition does not include a preservative; and
wherein the pharmaceutical composition has a moisture content of between about 3% and about 6%.
6 . The dry powder pharmaceutical composition of claim 5 , wherein a median particle diameter of the epinephrine or the pharmaceutically acceptable salt thereof is about 20 μm to about 75 μm.
7 . The dry powder pharmaceutical composition of claim 5 , wherein the carrier includes mannitol, a cyclodextrin, citric acid, lactose, and/or sodium carboxymethylcellulose.
8 . The dry powder pharmaceutical composition of claim 5 , wherein the quantity of the pharmaceutical composition is between about 5 mg and about 75 mg.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 16, 2024
From: LYMAN, SCOTT; BLESKE, BARRY EUGENE; LANPHER, TED WILLIAM
To: BELHAVEN BIOPHARMA INC.
Reel/Frame 068594/0393 →
Continuity (5)
Provisional Application
63209221
· Jun 10, 2021
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