Apparatus, methods, and systems for providing pharmaceutical compositions and administering medications to patients
Inventors
Albert, Pradeep • Nichols, Christine • Condron, David J. • Artze, Brian • SABA, Fadi • Klein, Jesse • Vad, Vijay • Naeger, Stephen
Assignees
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Publication Number
US-12194037-B2
Publication Date
2025-01-14
Expiration Date
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.
Core Innovation
The invention provides a pharmaceutical composition in the form of droplets for oral administration, where the pharmaceutical composition is an aqueous solution comprising sodium chloride present in an amount from 0.6% to 3% by weight per volume and at least one active ingredient present in a total amount from 0.025% to 25% by weight per volume. The at least one active ingredient is selected from naloxone, yohimbine, and albuterol, and the pharmaceutical composition has a pH of from 3 to 7.5.
Droplets are created so that each droplet consists of the pharmaceutical composition and has a diameter of from 1.5 to 5 microns. The invention further includes a process for preparing the droplet pharmaceutical composition by 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 aqueous solution into droplets by passing the aqueous solution through a vibrating mesh membrane undergoing piezoelectric vibration at a frequency of from 150 kHz to 300 KHz.
Claims Coverage
The document includes one independent claim with three inventive features, centered on formulation constraints, a vibrating-mesh piezoelectric atomization mechanism, and defined droplet size and composition.
Aqueous oral droplet pharmaceutical composition
A pharmaceutical composition in the form of droplets for oral administration comprising sodium chloride present in an amount of from 0.6% to 3% by weight per volume, at least one active ingredient present in a total amount of from 0.025% to 25% by weight per volume selected from naloxone, yohimbine, and albuterol, and a pH of from 3 to 7.5, wherein each droplet consists of the pharmaceutical composition.
Capsule-reservoir to atomizer droplet preparation
Preparing the pharmaceutical composition into the form of droplets by 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 droplets by passing the aqueous solution through a vibrating mesh membrane undergoing piezoelectric vibration at a frequency of from 150 kHz to 300 KHz.
Defined droplet diameter produced by vibrating mesh membrane
Each droplet created by the atomizer has a diameter of from 1.5 to 5 microns.
The independent claim covers an aqueous sodium chloride solution with naloxone and/or yohimbine and/or albuterol at a pH of 3 to 7.5, droplet formation via a capsule reservoir inserted into an atomizer and passed through a vibrating mesh membrane undergoing piezoelectric vibration, and droplets having a diameter of 1.5 to 5 microns with each droplet consisting of the pharmaceutical composition.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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