Patent ID: 11918655
Assignee: AEGIS THERAPEUTICS, LLC
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 13:
14. A method of treating a type-1 hypersensitivity reaction in a human comprising intranasally administering the human with the type-1 hypersensitivity reaction a nasal spray pharmaceutical formulation comprising in each dose about 5 mg/mL, about 6 mg/mL, about 7 mg/mL, about 8 mg/mL, about 9 mg/mL, about 10 mg/mL, about 11 mg/mL, about 12 mg/mL, about 13 mg/mL, about 14 mg/mL, about 15 mg/mL, about 16 mg/mL, about 17 mg/mL, about 18 mg/mL, about 19 mg/mL, or about 20 mg/mL of epinephrine, or a salt thereof, in a volume between about 50 μL and about 250 μL; wherein epinephrine, or a salt thereof, is the only pharmaceutically active ingredient in the nasal spray pharmaceutical formulation; an absorption enhancement agent as an excipient that is dodecyl maltoside; an isotonicity agent as an excipient that is sodium chloride; a stabilizing agent as an excipient that is ethylenediaminetetraacetic acid (EDTA) or disodium salt thereof; a preservative as an excipient that is benzalkonium chloride; an optional antioxidant as an excipient that is sodium metabisulfite; hydrochloric acid, sodium hydroxide, or both, as excipients in sufficient amounts to adjust the pH to a final pH between about 3.0 and about 5.0; and water;
wherein the type-1 hypersensitivity reaction comprises allergic asthma, allergic conjunctivitis, allergic rhinitis, anaphylaxis, angioedema, urticaria, eosinophilia, or combinations thereof;
wherein the intranasal administration of the nasal spray pharmaceutical formulation to the human with the type-1 hypersensitivity reaction provides plasma epinephrine concentrations in the human that are efficacious for the elimination of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction in the human; or
wherein the intranasal administration of the nasal spray pharmaceutical formulation to the human with the type-1 hypersensitivity reaction provides plasma epinephrine concentrations in the human that are efficacious for the prevention of the further progression of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction in the human.