# US 12,109,182 B2 · Administration of R-beta-hydroxybutyrate and related compounds in humans

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- Number: US 12,109,182 B2
- Document ID: US12109182B2
- Status: Granted
- Kind: B2
- Application number: 17/367,206
- Filed: 2021-07-02
- Published: 2021-12-23
- Granted: 2024-10-08
- Earliest claimed: 2016-04-19
- Assignees: Axcess Global Sciences, LLC
- Applicants: Axcess Global Sciences, LLC
- Inventors: Ryan Lowery; Jacob Wilson; Terry LaCore
- Web page: https://patentgrep.com/patent/US12109182B2

## CPC

- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- 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

In various implementations, beta-hydroxybutyrate, related compounds, and/or one or more other compounds may be administered to an individual to cause weight loss, weight maintenance, elevate blood ketone levels, maintain blood ketone levels, reduce blood glucose levels, maintain blood glucose levels, improve energy, focus, mood, cognitive function, or aide with neurological or inflammatory disorders and/or combinations thereof.

## Claims

### Claim 1

A composition for administering ketone bodies to a subject, comprising:
a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate,
wherein the non-racemic mixture contains from approximately 90% to less than 100% of R-beta-hydroxybutyrate and from greater than 0% to approximately 10% of S-beta-hydroxybutyrate,
wherein the composition is provided as or in a pill, tablet, capsule, powder, food product, food additive, milk, water, drinkable liquid, gel, or beverage.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the non-racemic mixture contains greater than approximately 95% and less than 100% of R-beta-hydroxybutyrate and greater than 0% and less than approximately 5% of S-beta-hydroxybutyrate.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the non-racemic mixture contains from approximately 90% to approximately 99% of R-beta-hydroxybutyrate and from approximately 1% to approximately 10% of S-beta-hydroxybutyrate.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the non-racemic mixture comprises at least one salt of R-beta-hydroxybutyrate.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the at least one salt of R-beta-hydroxybutyrate is selected from sodium R-beta-hydroxybutyrate, potassium R-beta-hydroxybutyrate, magnesium R-beta-hydroxybutyrate, and calcium R-beta-hydroxybutyrate.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the non-racemic mixture comprises at least one ester of R-beta-hydroxybutyrate.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the at least one ester of R-beta-hydroxybutyrate is selected from the group consisting of esters derived from ethanol, altrose, arabinose, dextrose, erythrose, fructose, galactose, glucose, glycerol, gulose, idose, lactose, lyxose, mannose, ribitol, ribose, ribulose, sucrose, talose, threose, xylitol, xylose, galactosamine, glucosamine, mannosamine, N-acetylglucosamine, mannitol, sorbitol, threitol, 1,2-propanediol, and 1,3-butanediol.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the R-beta-hydroxybutyrate comprises R-beta-hydroxybutyric acid.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the non-racemic mixture comprises an oligomer, polymer, or complex of R-beta-hydroxybutyrate.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the non-racemic mixture comprises at least one salt or ester of S-beta-hydroxybutyrate.

### Claim 11 (depends on 1)

The composition of claim 1, further comprising at least one short chain fatty acid having less than 6 carbons, or a monoglyceride, diglyceride, triglyceride, or other ester of the at least one short chain fatty acid.

### Claim 12 (depends on 1)

The composition of claim 1, further comprising at least one medium chain fatty acid having 6 to 12 carbons, or a monoglyceride, diglyceride, triglyceride, or other ester of the at least one medium chain fatty acid.

### Claim 13 (depends on 1)

The composition of claim 1, further comprising at least one long chain fatty acid having more than 12 carbons, or a monoglyceride, diglyceride, triglyceride, or other ester of the of the at least one long chain fatty acid.

### Claim 14 (depends on 1)

The composition of claim 1, further comprising at least one of 1,3-butanediol or tributyrin.

### Claim 15 (depends on 1)

The composition of claim 1, wherein the composition is in a dosage form that provides approximately 0.5 g to approximately 50 g of R-beta-hydroxybutyrate.

### Claim 16 (depends on 1)

The composition of claim 1, further comprising one or more flavorings, one or more vitamins, one or more minerals, and/or one or more binders.

### Claim 17 (depends on 1)

The composition of claim 1, wherein the composition further comprises at least one of an ester of R-beta-hydroxybutyrate or 1,3-butanediol.

### Claim 18

A composition for administering ketone bodies to a subject, comprising:
a dietetically or pharmaceutically acceptable carrier selected from the group consisting of pill, tablet, capsule, powder, food product, food additive, milk, water, drinkable liquid, gel, or beverage; and
a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate,
wherein the non-racemic mixture contains from approximately 90% to less than 100% of R-beta-hydroxybutyrate and from greater than 0% to approximately 10% of S-beta-hydroxybutyrate.

### Claim 19 (depends on 18)

The composition of claim 18, wherein the non-racemic mixture contains from approximately 95% to less than 100% of R-beta-hydroxybutyrate and from greater than 0% to approximately 5% of S-beta-hydroxybutyrate.

### Claim 20 (depends on 18)

The composition of claim 18, wherein the non-racemic mixture contains from approximately 90% to approximately 99% of R-beta-hydroxybutyrate and from approximately 1% to approximately 10% of S-beta-hydroxybutyrate.

### Claim 21

A composition for administering ketone bodies to a subject, comprising:
a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate,
wherein the non-racemic mixture contains from approximately 90% to less than 100% of R-beta-hydroxybutyrate and from greater than 0% to approximately 10% of S-beta-hydroxybutyrate,
wherein the R-beta-hydroxybutyrate comprises at least one salt of R-beta-hydroxybutyrate and R-beta-hydroxybutyric acid.

### Claim 22

A composition for administering ketone bodies to a subject, comprising:
1,3-butanediol; and
a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate,
wherein the non-racemic mixture contains from approximately 90% to less than 100% of R-beta-hydroxybutyrate and from greater than 0% to approximately 10% of S-beta-hydroxybutyrate.
