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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-11116723-B2
Publication Date
2021-09-14
Expiration Date
Abstract
A pharmaceutical composition in a form of dry powder for intranasal administration includes solid particles of at least one active agent and solid particles of a diluent. The pharmaceutical composition is substantially free of excipients other than the solid diluent. The pharmaceutical composition has at least 90% of the particles of the at least one active agent with a mean particle size of 10-30 microns and less than 10% of the particles of the at least one active agent with a mean particle size equal to or below 5 microns. The particles of the diluent have a mean particle size of 30-200 microns. An apparatus and method for preparation of the pharmaceutical composition utilize a spray-drying chamber, a cyclone separator, and a receiving chamber.
Core Innovation
The invention relates to intranasal administration pharmaceutical compositions in dry powder form. The compositions comprise at least one active agent in the form of solid particles and solid particles of a disaggregation agent, and are free of excipients or diluents other than the disaggregation agent. The composition has at least 90% of the active-agent solid particles with a mean particle size ranging from 10 microns to 30 microns, and less than 10% with mean particle size equal to or below 5 microns.
The invention further supports intranasal delivery that targets the uppermost region of the nasal cavity for nose-to-brain delivery to the brain via the olfactory region and associated pathways. The rationale described is to avoid lung deposition from small particles by constraining the active-agent particle-size distribution, while enabling delivery from the uppermost nasal region. The document links these constraints to transmucosal systemic delivery and central nervous system exposure.
The invention also includes a manufacturing approach using a spray-drying chamber with cyclone separator/vortex separation and a receiving chamber pre-filled with diluent, with continuous stirring and in-situ blending to produce the dry powder while preventing active-particle aggregation and preserving size and shape, including substantially spherical or ellipsoid morphology. Formulation and plume/spray-pattern evaluation using intranasal powder devices is described, together with particle-size characterization and in-vivo pharmacokinetic comparisons across selected active agents.
Claims Coverage
The provided claim set includes one independent claim that defines the intranasal dry powder composition and its particle-size constraints, with dependent claims refining disaggregation-agent characteristics, active-agent selection, intranasal targeting, and a preparation route. Across the claim family, there are at least four main inventive features.
Disaggregation-agent-only formulation for intranasal dry powder
A pharmaceutical composition in a form of dry powder for intranasal administration to a patient in need thereof, comprising at least one active agent in the form of solid particles and solid particles of a disaggregation agent, wherein the pharmaceutical composition is free of excipients or diluents other than the disaggregation agent.
Active-agent particle size distribution constraint
A pharmaceutical composition in a form of dry powder for intranasal administration to a patient in need thereof, wherein at least 90% of the solid particles of the at least one active agent have a mean particle size ranging from 10 microns to 30 microns, and less than 10% have a mean particle size equal to or below 5 microns.
Disaggregation agent particle mean size range
The pharmaceutical composition of claim 1, wherein the disaggregation agent has solid particles with a mean particle size ranging from 30 microns to 200 microns.
Lactose-related disaggregation-agent selection
The pharmaceutical composition of claim 1, wherein the disaggregation agent is lactose monohydrate, lactose, or a lactose functional analogue.
Uppermost nasal region nose-to-brain delivery
The pharmaceutical composition of claim 1 is administered intranasally to deliver an active agent from the uppermost region of the nasal cavity to the brain via nose-to-brain delivery.
The principal inventive scope is directed to an intranasal dry-powder pharmaceutical composition that is free of excipients or diluents other than disaggregation-agent particles, while enforcing a specified active-agent particle-size distribution. Dependent claim refinements further specify disaggregation-agent particle size, disaggregation-agent material, and an intranasal delivery constraint to the uppermost nasal region for nose-to-brain delivery.
Stated Advantages
Enables nose-to-brain delivery from the uppermost region of the nasal cavity to the brain via nose-to-brain delivery.
Avoids lung deposition from small particles by limiting the proportion of active-agent particles with mean particle size equal to or below 5 microns.
Provides faster plasma onset and higher brain exposure for intranasal powder compared with oral dosing in the described pharmacokinetic comparisons.
Documented Applications
Intranasal administration of a dry-powder pharmaceutical composition to deliver an active agent to the brain via nose-to-brain delivery from the uppermost region of the nasal cavity.
Intranasal delivery for transmucosal systemic administration is described at a conceptual level.
Formulation and plume/spray-pattern evaluation using intranasal powder devices.
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