# US 10,307,398 B2 · Resuscitation composition and methods of making and using

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- Number: US 10,307,398 B2
- Document ID: US10307398B2
- Status: Granted
- Kind: B2
- Application number: 15/710,389
- Filed: 2017-09-20
- Published: 2018-04-19
- Granted: 2019-06-04
- Earliest claimed: 2016-09-20
- Assignees: Regents of the University of Minnesota
- Applicants: Regents of the University of Minnesota
- Inventors: Gregory Beilman; Andrea Wolf; Raj Suryanarayanan; Seema Thakral
- Web page: https://patentgrep.com/patent/US10307398B2

## CPC

- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/40: Cyclodextrins; Derivatives thereof
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A resuscitation composition is described herein, as are methods of making and using such a composition.

## Claims

### Claim 1

A resuscitation composition comprising about 40 mM to 45 mM melatonin, about 3.8 M to about 4.2 M beta-hydroxybutyrate (BHB) or a pharmaceutically acceptable salt thereof in a solution of about 8% to about 12% hydroxypropyl-beta-cyclodextrin (HPbCD), about 4% to about 6% polyvinylpyrrolidone (PVP) and about 4% to about 6% polyethylene glycol (PEG).

### Claim 2 (depends on 1)

The composition of claim 1, comprising about 43 mM melatonin.

### Claim 3 (depends on 1)

The composition of claim 1, comprising about 4.0 M BHB.

### Claim 4 (depends on 1)

The composition of claim 1, comprising about 10% HPbCD, 5% PVP, and 5% PEG.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the pharmaceutically acceptable salt is Na-BHB.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the composition is lyophilized.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the composition further comprises a stabilizer.

### Claim 8 (depends on 1)

An article of manufacture comprising the composition of claim 1.

### Claim 9 (depends on 1)

A method for treating an individual who is experiencing or has experienced a major hemorrhagic event, comprising administering the composition of claim 1 to the individual.

### Claim 10 (depends on 9)

The method of claim 9, wherein the composition is administered to the individual before the individual has lost about 10% blood volume.

### Claim 11 (depends on 9)

The method of claim 9, wherein the composition is administered to the individual before the individual has lost about 20% blood volume.

### Claim 12 (depends on 9)

The method of claim 9, wherein the composition is administered to the individual before the individual has lost about 30%.blood volume.

### Claim 13 (depends on 9)

The method of claim 9, wherein the blood loss in the individual results in a systolic blood pressure of about 70 mm Hg or less.

### Claim 14 (depends on 9)

The method of claim 9, wherein the composition is administered at a volume of about 0.1 to about 5 milliliters (mls) per kilogram (kg) of weight of the individual.

### Claim 15 (depends on 9)

The method of claim 9, wherein the composition is administered at a volume of about 0.1 to about 5 mLs per kg of weight of the individual per hour.

### Claim 16 (depends on 9)

The method of claim 9, wherein the composition is administered intravenously or intraosseously.

### Claim 17 (depends on 9)

The method of claim 9, further comprising transfusing the individual with blood or plasma.