Drug delivery device and methods for using same
Inventors
MATHAI, Ashanthi • Frost, Michael • Kim, Serena • KOPPENHAGEN, Franciscus • Oringher, Seth
Assignees
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Publication Number
US-12285581-B2
Publication Date
2025-04-29
Expiration Date
Abstract
Devices for intranasal administration of naloxone are disclosed. The devices comprise a foam applicator and are configured to locate an applicator comprising a naloxone composition, in proximity to the middle turbinate and/or inferior turbinate. Naloxone can be delivered to the nasal mucosa by squeezing the nostril against the applicator. The device and methods of using the devices can be used to treat an opioid overdose.
Core Innovation
The invention relates to a nasal mucosal delivery device for use in treating an opioid overdose. The device includes a handle with a proximate end and a distal end, a nasal stop attached toward the distal end, and an applicator coupled to the distal end. The nasal stop is configured to rest against an anterior naris during use and to resist further penetration of the applicator into a nasal cavity.
The applicator comprises a compressible polyurethane foam that does not comprise microneedles. The foam is characterized by its ability to hold and release a pre-determined dose of naloxone with a relative standard deviation of less than 6%. The device is configured to hold from 70 µL to 350 µL of a naloxone hydrochloride composition and to release a dose of the naloxone hydrochloride composition for treating an opioid overdose by squeezing a nostril against the compressible polyurethane foam.
The invention further defines dose and positioning relationships. The device contains from 1 mg to 20 mg of naloxone hydrochloride, and the distance between the nasal stop and the distal end of the applicator is from 15 mm to 30 mm. In the disclosed compositions, naloxone hydrochloride is provided as a naloxone hydrochloride composition with described excipients and a pH range.
Claims Coverage
The independent claim defines a nasal mucosal delivery device for treating an opioid overdose with a compressible polyurethane foam applicator, quantitative dose-holding/release constraints, nasal stop positioning constraints, and performance consistency characterized by relative standard deviation of less than 6%. The associated dependent claims further refine the foam structure, formulation details, and pharmacokinetic constraints.
Nasal mucosal delivery device for treating an opioid overdose
A nasal mucosal delivery device for use in treating an opioid overdose, comprising a handle with a proximate end and a distal end, a nasal stop attached toward the distal end, and an applicator coupled to the distal end.
Compressible polyurethane foam applicator without microneedles
An applicator comprising a compressible polyurethane foam that does not comprise microneedles.
Predetermined naloxone dose consistency
The compressible polyurethane foam is characterized by its ability to hold and release a pre-determined dose of naloxone with a relative standard deviation of less than 6%.
Dose volume and naloxone hydrochloride content for nasal squeezing delivery
The compressible polyurethane foam is configured to hold from 70 µL to 350 µL of a naloxone hydrochloride composition and to release a dose of the naloxone hydrochloride composition for treating an opioid overdose by squeezing a nostril against the compressible polyurethane foam, and contains from 1 mg to 20 mg of naloxone hydrochloride.
Nasal stop positioning and penetration resistance
The nasal stop is configured to rest against an anterior naris during use and to resist further penetration of the applicator into a nasal cavity.
Stop-to-applicator distance constraint
The distance between the nasal stop and the distal end of the applicator is from 15 mm to 30 mm.
Overall, the claims coverage centers on delivering naloxone hydrochloride intranasally using a compressible polyurethane foam applicator (no microneedles) coupled with a nasal stop that positions the applicator and resists further penetration, while meeting dose-volume, naloxone-content, and dose-consistency constraints and releasing the dose by squeezing the nostril against the foam.
Stated Advantages
Holds and releases a pre-determined naloxone dose with relative standard deviation of less than 6%.
Improved pharmacokinetic performance is described in the disclosed support, including a Tmax threshold (Tmax less than 0.3 (+10%) hours) in a patient population.
Documented Applications
Treating an opioid overdose using a nasal mucosal delivery device with an applicator that releases a naloxone hydrochloride dose by squeezing a nostril against a compressible polyurethane foam.
Providing plasma naloxone pharmacokinetic profiles after administration to a population of patients, including a Tmax less than 0.3 (+10%) hours.
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