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Assignees
Member
Nasus PharmaNasus Pharma develops powder-based intranasal therapies for acute, life-threatening medical emergencies. The company focuses on rapid and predictable drug absorption using a scalable proprietary platform. Their pipeline includes clinical-stage candidates for anaphylaxis, opioid overdose, and chemotherapy-induced nausea, emphasizing needle-free, stable, and portable drug delivery alternatives backed by clinical data. Nasus Pharma's mission is to address urgent medical needs through innovative intranasal formulations that offer faster onset and greater convenience than traditional injectables.
Nasus Pharma develops powder-based intranasal therapies for acute, life-threatening medical emergencies. The company focuses on rapid and predictable drug absorption using a scalable proprietary platform. Their pipeline includes clinical-stage candidates for anaphylaxis, opioid overdose, and chemotherapy-induced nausea, emphasizing needle-free, stable, and portable drug delivery alternatives backed by clinical data. Nasus Pharma's mission is to address urgent medical needs through innovative intranasal formulations that offer faster onset and greater convenience than traditional injectables.
Publication Number
US-11400045-B2
Publication Date
2022-08-02
Expiration Date
Abstract
Disclosed is a pharmaceutical composition in dry powder form for intranasal administration, having an anti-anaphylactic adrenergic receptor agonist in the form of dry powder for intranasal administration, the composition having solid particles of the active agent in combination with at least one functional additive, and solid particles of an inert carrier.
Core Innovation
Dry powder intranasal pharmaceutical compositions are provided for treating anaphylaxis, wherein an anti-anaphylactic adrenergic receptor agonist is administered as a two-particle system. The system includes first type of solid essentially spherical particles and a second type of solid particles. The first type of solid particles include a homogenous combination of at least one anti-anaphylactic adrenergic receptor agonist active agent and at least one pH adjusting/buffering agent, and the second type of solid particles comprise a pharmaceutically acceptable carrier.
The particle populations are defined by mean particle size ranges and distribution constraints. At least 90% of the first type of solid particles have a mean particle size of 10-30 microns, and less than 10% have a mean particle size equal to or below 10 microns, while the second type of solid particles have a mean particle size of 50-200 microns. The composition can be substantially free of excipients other than the pH adjusting/buffering agent and the pharmaceutically acceptable carrier.
For specific embodiments, the active agent is epinephrine or a pharmaceutically acceptable salt thereof, including epinephrine bitartrate, combined with physiologically acceptable di-sodium hydrogen phosphate within the essentially spherical particles, and lactose monohydrate as the carrier in the second type of particles. Disposable intranasal metered dose units and kits with instructions are disclosed, together with therapeutic methods for administering the composition to patients with anaphylactic shock.
Claims Coverage
The document provides coverage via two independent claims directed to dry powder intranasal anti-anaphylactic adrenergic receptor agonist compositions, one generic and one specific to epinephrine. The independent claims share a two-type-particle architecture with specified particle-size distributions and metered-dose therapeutic framing, with the second independent claim further requiring specific active-agent and excipient embodiments and a metered therapeutically effective nominal dose.
Two-type solid particle dry powder intranasal anti-anaphylactic composition
A pharmaceutical composition for intranasal administration comprising an anti-anaphylactic adrenergic receptor agonist in the form of dry powder, including a first type of solid essentially spherical particles with a homogenous combination of at least one anti-anaphylactic adrenergic receptor agonist active agent and at least one pH adjusting/buffering agent, and a second type of solid particles comprising a pharmaceutically acceptable carrier.
First and second particle size distribution constraints for intranasal delivery
The composition where at least 90% of the first type of solid particles are of a mean particle size of 10-30 microns and less than 10% of said first type of solid particles are of a mean particle size equal to or below 10 microns, and where said second type of solid particles have a mean particle size of 50-200 microns.
Epinephrine plus di-sodium hydrogen phosphate in essentially spherical particles with lactose monohydrate carrier
An epinephrine pharmaceutical composition in the form of dry powder for intranasal administration comprising epinephrine or a pharmaceutically acceptable salt thereof, where the first type of solid essentially spherical particles each consist of a homogenous combination of epinephrine or a pharmaceutically acceptable salt thereof and a physiologically acceptable di-sodium hydrogen phosphate, and where the second type of solid particles comprise lactose monohydrate as carrier.
Epinephrine metered therapeutically effective nominal dose with specified particle size distributions
At least 90% of the first type of solid particles are of a mean particle size of 10-30 microns and less than 10% of said first type of solid particles are of a mean particle size equal to or below 10 microns and said second type of solid particles are of a mean particle size of 50-200 microns, providing a metered therapeutically effective nominal dose of said epinephrine or pharmaceutically acceptable salt thereof.
Across the independent claims, the core claim coverage centers on dry powder intranasal formulations using a two-type particle system in which essentially spherical, homogenous active-agent/pH-adjusting particles are combined with a separate carrier particle type. The claims further require specific particle-size distribution constraints for both particle types and, in the epinephrine-specific independent claim, require defined excipient embodiments and a metered therapeutically effective nominal dose.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating anaphylactic shock by administering a dose unit or administering a pharmaceutical composition to a patient in need.
Administering the dry powder composition intranasally using a disposable intranasal metered dose unit delivering a metered dose of an anti-anaphylactic adrenergic receptor agonist.
Providing a kit for intranasal administration including intranasal dose units and instructions for use.
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