IP Library Granted Patent US 12,194,037
Granted Patent B2
US 12,194,037 · App. 18/529,978 · Granted Jan 14, 2025

Apparatus, methods, and systems for providing pharmaceutical compositions and administering medications to patients

Inventors: Pradeep Albert (Sarasota, FL); Christine Nichols (Largo, FL); David J. Condron (Seminole, FL); Brian Artze (Gulfport, FL); Fadi Saba (St Petersburg, FL); Jesse Klein (Clearwater, FL); Vijay Vad (New York, NY); Stephen Naeger (Largo, FL)
A61K31/485A61K9/0078A61K9/08A61K31/137A61K31/4164A61K31/475A61K47/02A61M11/00A61M15/003
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Quick Facts
Patent No.
US 12,194,037
App. No.
18/529,978
Filed
Dec 5, 2023
Granted
Jan 14, 2025
Kind
B2
Art Unit
1615
USPC
424/400
Abstract

A pharmaceutical composition and method for treating opioid overdose, opioid dependency, and xylazine exposure is disclosed, utilizing an aqueous solution of sodium chloride. This solution contains active ingredients such as naloxone and yohimbine in specific concentrations, with naloxone targeting opioid overdose and yohimbine aimed at counteracting xylazine effects. In various embodiments, additional components like tolazoline and different buffers can be included. The disclosure introduces a unique delivery system that features a capsule with a vibrating mesh atomizer for efficient administration. Specifically, for yohimbine, a dual-reservoir capsule design facilitates controlled mixing with diluents or buffers. The administration of this pharmaceutical composition can be achieved through multiple methods, including intramuscular, intravenous, and atomized routes. The atomizing device incorporates a removable cap and a resilient air bladder, ensuring effective drug delivery. This system offers precision and adaptability in treating conditions related to opioid overdose, dependency, and xylazine exposure.

Claims (9)

1. A pharmaceutical composition in the form of droplets for oral administration to a patient, wherein the pharmaceutical composition is an aqueous solution comprising sodium chloride present in an amount of from 0.6% to 3% by weight per volume of the pharmaceutical composition; at least one active ingredient present in a total amount of from 0.025% to 25% by weight per volume of the pharmaceutical composition, the at least one active ingredient selected from the group consisting of naloxone, yohimbine, and albuterol; and having a pH of from 3 to 7.5; and wherein the pharmaceutical composition is prepared into the form of droplets by the process comprising:

providing the pharmaceutical composition in a reservoir of a capsule;

inserting the capsule into a receiving section of an atomizer; and

activating the atomizer to convert the pharmaceutical composition into the form of droplets by passing the aqueous solution through a vibrating mesh membrane undergoing piezoelectric vibration at a frequency of from 150 kHz to 300 KHz;

wherein each droplet created by the atomizer has a diameter of from 1.5 to 5 microns and wherein each droplet consists of the pharmaceutical composition.

2. The pharmaceutical composition of claim 1 , wherein the at least one active ingredient is naloxone present in an amount of from 4% to 6% by weight per volume of the pharmaceutical composition.

3. The pharmaceutical composition of claim 1 , wherein, the at least one active ingredient is yohimbine present in an amount of from 2.5% to 6% by weight per volume of the pharmaceutical composition.

4. The pharmaceutical composition of claim 1 , wherein, the at least one active ingredient is albuterol present in an amount of from 0.025% to 0.075% by weight per volume of the pharmaceutical composition.

5. The pharmaceutical composition of claim 1 , further comprising tolazoline present in an amount of from 50% to 75% by weight per volume of the pharmaceutical composition.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 3, 2024
From: ALBERT, PRADEEP, M.D.; NICHOLS, CHRISTINE; CONDRON, DAVID J.; ARTZE, BRIAN; SABA, FADI, M.D.; KLEIN, JESSE, D.O.; VAD, VIJAY, M.D.; NAEGER, STEPHEN, RPH
To: MICRONEB TECH HOLDINGS, INC.
Reel/Frame 068472/0234 →
Continuity (6)
Continuation In Part 18373142 · Sep 26, 2023
Continuation In Part 18449838 · Aug 15, 2023
Continuation In Part 18224502 · Jul 20, 2023
Continuation In Part 18207242 · Jun 8, 2023
Provisional Application 63437568 · Jan 6, 2023
Related Publication 20240226092A1 · Jul 11, 2024
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