Dry powder compositions for intranasal delivery
Inventors
TEMTSIN-KRAYZ, Galia • Megiddo, Dalia • Lapidot, Tair • Abrutzky, Carolina
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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-11844859-B2
Publication Date
2023-12-19
Expiration Date
Abstract
Dry powder pharmaceutical compositions for intranasal administration include an opioid receptor antagonist, e.g. naloxone, as active ingredient, and dosage unit forms thereof. Methods of treating opioid overdose include administering the dry powder compositions.
Core Innovation
The invention relates to a pharmaceutical composition in the form of a dry powder for intranasal administration that includes at least one opioid receptor antagonist as an active ingredient. The composition comprises opioid receptor antagonist solid particles and pharmaceutically acceptable disaggregating agent solid particles, with defined particle-size distributions for the antagonist particles and a disaggregating-agent particle size that is greater than that of the antagonist particles.
In disclosed embodiments, at least about 90% of the opioid receptor antagonist solid particles have a mean particle size of about 10 to about 30 microns, while less than about 10% of the antagonist particles are of a mean particle size equal to or below about 10 microns. The disaggregating agent solid particles are specified as having a mean particle size greater than that of the opioid receptor antagonist solid particles, and the use of the disaggregating agent is described as a way to prevent aggregation while maintaining the intended dry-powder structure and performance.
A specific disclosed instance is a naloxone pharmaceutical composition in dry-powder form for intranasal administration, comprising naloxone or a pharmaceutically acceptable salt and lactose monohydrate solid particles as a disaggregation agent. The invention further describes providing a metered therapeutically effective nominal dose of naloxone, including delivery concepts such as a disposable dose unit and intranasal performance targeting that emphasizes delivery to the turbinates or uppermost nasal cavity and comparatively reduced lung delivery.
Claims Coverage
The partial claims provided include two independent claims. Both independently focus on dry-powder intranasal pharmaceutical compositions with defined particle-size distributions separating opioid receptor antagonist particles from disaggregating-agent particles; the second independent claim specializes the composition as a naloxone and lactose monohydrate formulation and adds a metered nominal dose concept.
Dry powder intranasal opioid receptor antagonist with antagonist/disaggregating particle-size distribution
A pharmaceutical composition in a form of dry powder for intranasal administration, comprising at least one opioid receptor antagonist as active ingredient, said composition comprising opioid receptor antagonist solid particles and pharmaceutically acceptable disaggregating agent solid particles, wherein at least 90% of said opioid receptor antagonist solid particles are of a mean particle size of about 10 to about 30 microns, less than about 10% are of a mean particle size equal to or below about 10 microns, and said disaggregating agent solid particles are of a mean particle size greater than that of said opioid receptor antagonist solid particles.
Dry powder intranasal naloxone with lactose monohydrate disaggregation agent and metered nominal dose
A naloxone pharmaceutical composition in the form of dry powder for intranasal administration, comprising naloxone or a pharmaceutically acceptable salt thereof solid particles and lactose monohydrate solid particles as disaggregation agent, wherein at least about 90% of said solid particles are of a mean particle size of about 10 to 30 microns, less than about 10% are of a mean particle size equal to or below about 10 microns, said lactose monohydrate solid particles are of a mean particle size greater than that of said naloxone or pharmaceutically acceptable salt thereof solid particles, and the composition provides a metered therapeutically effective nominal dose.
Across the two independent claims, the coverage centers on intranasal dry-powder compositions where the opioid receptor antagonist particle fraction is constrained to mostly about 10 to 30 microns with a limited fine fraction at or below about 10 microns, while disaggregating-agent particles have a larger mean particle size than the antagonist particles; the naloxone independent claim additionally specifies lactose monohydrate as the disaggregation agent and requires a metered therapeutically effective nominal dose.
Stated Advantages
The use of the disaggregating agent is described as a way to prevent aggregation while maintaining the intended dry-powder structure and performance.
Documented Applications
Intranasal administration.
Delivery to the turbinates or uppermost nasal cavity with comparatively reduced lung delivery.
Disposable dose unit.
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