Compositions, devices, and methods for intranasal delivery of dry powder epinephrine
AssigneeBelhaven BioPharma Inc.
InventorsScott Lyman, Brian Taubenheim
Life of this patent
Estimating the term…
Abstract
Intranasal dry powder epinephrine compositions are described herein. The compositions include epinephrine or a pharmaceutically acceptable salt thereof, as well as a stabilizing agent and a carrier. The stabilizing agent is operable to include citric acid, or a pharmaceutically acceptable salt derived therefrom. Such intranasal compositions as described herein are useful in the treatment of health conditions which threaten the central nervous system (CNS) and impede the actions of alpha and beta-adrenergic receptors. Such health conditions include anaphylaxis, bronchospasms, respiratory impairment, organophosphate poisoning, and major adverse cardiac events (MACE).
Claims20
An apparatus for delivery of a spray dried powder pharmaceutical composition, the apparatus comprising:
- a reservoir containing a dose of the spray dried powder pharmaceutical composition, wherein the spray dried powder pharmaceutical composition comprises epinephrine or a pharmaceutically acceptable salt thereof and a carrier, wherein the spray dried powder pharmaceutical composition has a bulk particle size distribution characterized by a Dv50 of between about 5 microns and about 30 microns;
- an air delivery assembly configured to be placed in fluid communication with the reservoir;
- and
- a delivery head operatively coupled to the reservoir, wherein the delivery head defines a delivery aperture;
- wherein upon actuation of the apparatus, the air delivery assembly is configured to produce an airflow through the reservoir to deliver a mixture of the airflow and the dose of the spray dried powder pharmaceutical composition via the delivery aperture, wherein the mixture has an emitted particle size distribution characterized by a Dv50 of between about 15 microns and about 200 microns and that is greater than the Dv50 of the bulk particle size distribution.
An apparatus for delivery of a spray dried powder pharmaceutical composition, the apparatus comprising:
- a reservoir containing a dose of the spray dried powder pharmaceutical composition, wherein the spray dried powder pharmaceutical composition comprises epinephrine or a pharmaceutically acceptable salt thereof, wherein the spray dried powder pharmaceutical composition has a bulk particle size distribution characterized by a Dv50 of between about 5 microns and about 18 microns;
- an air delivery assembly configured to be placed in fluid communication with the reservoir;
- and
- a delivery head operatively coupled to the reservoir, the delivery head defining a delivery aperture;
- wherein upon actuation of the apparatus, the air delivery assembly is configured to produce an airflow through the reservoir to deliver a mixture of the airflow and the dose of the spray dried powder pharmaceutical composition via the delivery aperture, wherein the mixture has an emitted particle size distribution characterized by a Dv50 of between about 20 microns and about 185 microns and that is greater than the Dv50 of the bulk particle size distribution.
A spray dried powder pharmaceutical composition comprising:
- epinephrine or a pharmaceutically acceptable salt thereof;
- and
- a carrier;
- wherein a single dose of the spray dried powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or the pharmaceutically acceptable salt thereof;
- wherein the spray dried powder pharmaceutical composition has a bulk particle size distribution characterized by a Dv50 of between about 5 microns and about 30 microns;
- and
- wherein the spray dried powder pharmaceutical composition is formulated such that intranasal delivery of the dose of the spray dried powder pharmaceutical composition through an apparatus comprising an air delivery assembly and a delivery aperture produces a spray having an emitted particle size distribution characterized by a Dv50 of between about 15 microns and about 200 microns and that is greater than the Dv50 of the bulk particle size distribution.
Dependencies are inferred from the claim text.