Granted Patent B2

US 12,194,263 · App. 17/523,321 · Granted Jan 14, 2025

Inventor: Ashanthi Mathai (Bethesda, MD)

Assignee: Pocket Naloxone Corp.

A61M31/00A61K9/0043A61K9/08A61K31/485A61M2205/3368A61M2210/0618

Abstract

Claims (14)

1. An intranasal delivery device for treating an opioid overdose comprising:

a nasal applicator comprising a shaft and an applicator tip coupled to the shaft; and

an absorbent swab material coupled to the applicator tip, wherein,

the absorbent swab material is preloaded with a pre-metered dose comprising from 50 μL to 450 μL of an aqueous naloxone-containing formulation for treating an opioid overdose, wherein,

the naloxone-containing formulation has:

a naloxone HCI concentration of at least 45 mg/mL; and

a pH from 3.5 to 5.5; and

the pre-metered dose comprises from 1 mg to 20 mg of naloxone HCl;

the absorbent swab material is configured to hold the naloxone-containing formulation and to release the pre-metered dose of the naloxone-containing formulation when pressed against the nasal mucosa; and

the nasal applicator is configured to contact the absorbent swab material to the nasal mucosa between from 1.5 cm to 3.0 cm from an opening of the nasal passage; and

the applicator tip does not comprise an injection mechanism.

2. The intranasal delivery device of claim 1 , wherein the naloxone-containing formulation has a naloxone HCl concentration from 45 mg/mL to 90 mg/mL.

3. The intranasal delivery device of claim 1 , wherein the naloxone-containing formulation comprises a stabilizing agent, a tonicity agent, a chelating agent, and a preservative.

4. The intranasal delivery device of claim 1 , wherein the pre-metered dose comprises from 100 μL to 300 μL of a naloxone-containing formulation having a concentration of naloxone-HCl from 45 mg/mL to 90 mg/mL.

Assignments (3)

Continuity (5)

References Cited (188)