Compositions, devices, and methods for intranasal delivery of dry powder epinephrine
AssigneeBelhaven BioPharma Inc.
InventorsScott Lyman, Brian Taubenheim
Life of this patent
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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).
Claims15
A method of intranasally delivering a dry powder pharmaceutical composition, comprising:
- placing a delivery head of an intranasal device into a nasal passage of a body, wherein the intranasal device includes a reservoir containing a dose of the dry pharmaceutical composition, wherein the dry powder pharmaceutical composition comprises epinephrine or a pharmaceutically acceptable salt thereof and a carrier, wherein the dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof, wherein intranasally delivering the dose of the dry powder pharmaceutical composition causes at least one of:
- (A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or
- (B) a time to reach a maximum epinephrine plasma concentration (Tmax) greater than a Tmax of the first reference dose and less than a Tmax of the second reference dose;
- wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector, and
- actuating the intranasal device to deliver the dose of the dry powder pharmaceutical composition into the body.
A method of intranasally delivering a dry powder pharmaceutical composition, comprising:
- intranasally administering into a nasal passage of a body, via an intranasal device, a single dose of the dry powder pharmaceutical composition comprising about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof and a carrier;
- causing, by intranasally administering the single dose of the dry powder pharmaceutical composition, at least one of:
- (A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or
- (B) a time to reach a maximum epinephrine plasma concentration (Tmax) is greater than a Tmax of the first reference dose and less than a Tmax of the second reference dose;
- wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector.
Dependencies are inferred from the claim text.