Intranasal epinephrine formulations and methods for the treatment of disease
Inventors
Lowenthal, Richard • Maggio, Edward T. • Bell, Robert G. • Shah, Pratik
Assignees
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Publication Number
US-10682414-B2
Publication Date
2020-06-16
Expiration Date
Abstract
Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.
Core Innovation
The invention relates to intranasal administration of epinephrine as an anaphylaxis active ingredient for treating a type-1 hypersensitivity reaction in a mammal. An aqueous nasal spray pharmaceutical formulation is administered intranasally to a mammal in need thereof, and the formulation comprises epinephrine, or a salt thereof, provided in a single dose within a defined mass range.
A central feature is combining the aqueous nasal spray pharmaceutical formulation with defined epinephrine dosing per single dose together with formulation components that support intranasal bioavailability. The formulation includes one or more absorption enhancement agents, including alkylsaccharide absorption enhancers, alkylglycosides, benzalkonium chloride, and oleic acid or salts, and discusses absorption enhancers in relation to intramuscular-injection-like pharmacokinetics.
The invention also includes nasal spray dosing and stability-related formulation parameters, including pH adjustment agents and pH range, and optional excipient classes such as isotonicity agents, stabilizers/chelators, preservatives, and antioxidants. In addition, the document describes intranasal delivery device and kit concepts, including a metered spray pump, single actuation dose, droplet size distribution, dose reproducibility, packaging, and labeling concepts.
Claims Coverage
The independent claims cover one inventive feature: a method of treating a type-1 hypersensitivity reaction by intranasally administering an aqueous nasal spray pharmaceutical formulation with a defined epinephrine or salt single-dose range.
Intranasal treatment with an aqueous nasal spray formulation
A method of treatment of a type-1 hypersensitivity reaction in a mammal comprising administering intranasally an aqueous nasal spray pharmaceutical formulation.
Epinephrine anaphylaxis active ingredient in a defined single-dose range
The aqueous nasal spray pharmaceutical formulation comprises an anaphylaxis active ingredient consisting of between about 0.1 mg and about 2.4 mg of epinephrine, or a salt thereof in a single dose.
The claim coverage centers on intranasal treatment using an aqueous nasal spray formulation containing epinephrine or a salt as the anaphylaxis active ingredient within a specified single-dose mass range.
Stated Advantages
Absorption enhancers can yield intramuscular-injection-like pharmacokinetics.
Documented Applications
Treating a type-1 hypersensitivity reaction in a mammal by intranasal administration of an aqueous nasal spray pharmaceutical formulation containing epinephrine or a salt.
Treatment of anaphylaxis and systemic allergic reaction conditions described as part of the type-1 hypersensitivity reaction set, including allergic asthma, allergic rhinitis, allergic conjunctivitis, angioedema, urticaria, eosinophilia, drug allergy, food allergy, cardiac arrest, and Stokes-Adams syndrome.
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