Mixed salt compositions for producing elevated and sustained ketosis

• US 10,736,861 B2
• Filed: 02/11/2019
• Issued: 08/11/2020
• Est. Priority Date: 03/11/2016
• Status: Active Grant

• Current Assignee: Axcess Global Sciences, LLC (Axcess Global, LLC)
• Original Assignee: Axcess Global Sciences, LLC (Axcess Global, LLC)
• Inventors: Millet, Gary
• Primary Examiner(s): Ricci, Craig D
• Assistant Examiner(s): Coppins, Janet L.
• Application Number:
  US16/272,145
• Publication Number:
  US 20190167613A1
• Time in Patent Office: 547 Days
• Field of Search: 514167
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23L 33/175 Amino acids
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/30 Foods, ingredients or supplements having a functional effect on health
• CPC Class Codes: A23V 2250/02 Acid
• CPC Class Codes: A23V 2250/06 Amino acid
• CPC Class Codes: A23V 2250/1578 Calcium
• CPC Class Codes: A23V 2250/16 Potassium
• CPC Class Codes: A23V 2250/161 Magnesium
• CPC Class Codes: A23V 2250/1614 Sodium
• CPC Class Codes: A23V 2250/1876 Long-chain fatty acids
• CPC Class Codes: A23V 2250/1878 Medium-chain fatty acids
• CPC Class Codes: A23V 2250/1884 Short-chain fatty acids
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/02 : Suppositories; Bougies; Bases therefor; Ovulesapparatus for making A61J3/08; devices for introducing into the body A61M31/00
• CPC Class Codes: A61K 9/14 : Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61K 9/145 : with organic compounds
• CPC Class Codes: A61K 9/2004 : Excipients; Inactive ingredients
• CPC Class Codes: A61K 9/2013 : Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/4841 : Filling excipients; Inactive ingredients
• CPC Class Codes: A61K 9/4858 : Organic compounds
• CPC Class Codes: A61P 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00

Abstract

Ketogenic compositions including a beta-hydroxybutyrate (BHB) mixed salt are formulated to induce or sustain ketosis in a subject to which the ketogenic compositions are administered. The BHB mixed salt is formulated to provide a biologically balanced set of cationic electrolytes, and is formulated to avoid detrimental health effects associated with imbalanced electrolyte ratios. A ketogenic composition includes BHB salts of at least sodium, potassium, calcium, and magnesium. The BHB salts may also include at least other component such as a BHB compound containing other cations, such as transition metal cations (e.g., zinc or iron), a BHB-amino acid salts, medium chain fatty acid source, vitamin D₃, flavorant, or other excipient.

Claims

1. A kit for use in increasing ketone level in a subject, comprising:

a beta-hydroxybutyrate mixed salt composition in solid or powder form comprising;

sodium beta-hydroxybutyrate;

potassium beta-hydroxybutyrate;

calcium beta-hydroxybutyrate; and

magnesium beta-hydroxybutyrate;

a container in which the beta-hydroxybutyrate mixed salt composition in solid or powder form is placed; and

a measuring device configured to hold therein a unit dose, or fraction thereof, of the composition in solid or powder form, wherein a unit dose of the composition contains about 1 g to about 50 g of beta-hydroxybutyrate mixed salt.

2. The kit of claim 1, wherein the container is selected from the group consisting of carton, box, can, jar, bag, pouch, bottle, jug, and keg.

3. The kit of claim 1, wherein the measuring device is selected from the group consisting of cup, scoop, spatula, syringe, dropper, colonic irrigation device, and spoon.

4. The kit of claim 1, wherein the container includes instructions regarding the size of the unit dose, or fraction thereof, and the manner or frequency of administration.

5. The kit of claim 1, the composition further comprising at least one medium chain fatty acid having 6 to 12 carbons, or a mono-, di- or triglyceride of the at least one medium chain fatty acid.

6. The kit of claim 1, the composition further comprising at least one short chain fatty acid having less than 6 carbons, or a mono-, di- or triglyceride of the at least one short chain fatty acid.

7. The kit of claim 1, the composition further comprising at least one long chain fatty acid having more than 12 carbons, or a mono-, di- or triglyceride of the at least one short chain fatty acid.

8. The kit of claim 1, the composition further comprising at least one vitamin or mineral selected from vitamin D3, lithium, chromium, manganese, cobalt, copper, zinc, iron II, iron III, molybdenum, or selenium.

9. The kit of claim 8, wherein the composition comprises about 5 μ

g to about 200 μ

g and/or about 200 IU to about 8000 IU of vitamin D_3.

10. The kit of claim 9, wherein the composition comprises zinc, copper, manganese, and chromium.

11. The kit of claim 1, wherein the composition further comprises at least one of calcium silicate or calcium phosphate salt.

12. The kit of claim 1, wherein the beta-hydroxybutyrate mixed salt composition comprises a higher amount of the potassium beta-hydroxybutyrate than the sodium beta-hydroxybutyrate.

13. The kit of claim 1, wherein the beta-hydroxybutyrate mixed salt composition comprises at least 10% by weight of calcium beta-hydroxybutyrate.

14. The kit of claim 1, wherein the beta-hydroxybutyrate mixed salt composition comprises at least 10% by weight of magnesium beta-hydroxybutyrate.

15. A kit for use in increasing ketone level in a subject, comprising:

a beta-hydroxybutyrate mixed salt composition in solid or powder form comprising;

sodium beta-hydroxybutyrate;

potassium beta-hydroxybutyrate;

calcium beta-hydroxybutyrate; and

magnesium beta-hydroxybutyrate;

a container in which the beta-hydroxybutyrate mixed salt composition in solid or powder form is placed, wherein the container is selected from the group consisting of carton, box, can, jar, bag, pouch, bottle, jug, and keg; and

a measuring device configured to hold therein a unit dose, or fraction thereof, of the composition in solid or powder form, wherein the measuring device is selected from the group consisting of cup, scoop, spatula, syringe, dropper, colonic irrigation device, and spoon, and wherein a unit dose of the composition contains about 1 g to about 50 g of beta-hydroxybutyrate mixed salt.

16. The kit of claim 15, wherein the composition further comprises vitamin D_3, zinc, copper, manganese, chromium, calcium silicate, and calcium phosphate.

17. A kit for use in increasing ketone level in a subject, comprising:

a beta-hydroxybutyrate mixed salt composition in solid or powder form comprising;

sodium beta-hydroxybutyrate;

potassium beta-hydroxybutyrate;

at least 10% by weight of calcium beta-hydroxybutyrate; and

at least 10% by weight of magnesium beta-hydroxybutyrate;

a container in which the beta-hydroxybutyrate mixed salt composition in solid or powder form is placed; and

a measuring device configured to hold therein a unit dose, or fraction thereof, of the composition in solid or powder form, wherein a unit dose of the composition contains about 1 g to about 50 g of beta-hydroxybutyrate mixed salt.

18. The kit of claim 17, wherein the beta-hydroxybutyrate mixed salt composition comprises at least 10% by weight of potassium beta-hydroxybutyrate.

19. The kit of claim 17, wherein the beta-hydroxybutyrate mixed salt composition comprises at least 10% by weight of sodium beta-hydroxybutyrate.

20. The kit of claim 17, wherein the beta-hydroxybutyrate mixed salt composition comprises a higher amount of the potassium beta-hydroxybutyrate than the sodium beta-hydroxybutyrate.