Methods and compositions for sustained release of chromium

• US 9,597,404 B2
• Filed: 07/21/2015
• Issued: 03/21/2017
• Est. Priority Date: 03/13/2007
• Status: Active Grant

• Current Assignee: Nutrition21 LLC
• Original Assignee: JDS Therapeutics LLC
• Inventors: Komorowski, James R.
• Primary Examiner(s): STANFIELD, CHERIE MICHELLE
• Application Number:
  US14/805,034
• Publication Number:
  US 20150320874A1
• Time in Patent Office: 609 Days
• US Class Current: 1/1
• CPC Class Codes: A23L 33/165 Complexes or chelates
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/1586 Chromium
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/28 Compounds containing heavy metals
• CPC Class Codes: A61K 31/4172 Imidazole-alkanecarboxylic acids, e.g. histidine
• CPC Class Codes: A61K 31/4402 only substituted in position 2, e.g. pheniramine, bisacodyl
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 47/545 Heterocyclic compounds A61K47/558 takes precedence
• CPC Class Codes: A61K 47/547 Chelates, e.g. Gd-DOTA or Zinc-amino acid chelates; Chelate-forming compounds, e.g. DOTA or ethylenediamine being covalently linked or complexed to the pharmacologically- or therapeutically-active agent
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Provided herein are compositions for the administration of chromium that include at least two components: a hydrophilic chromium complex and a lipophilic chromium complex, and methods of using the same. Also provided are compositions for the administration of chromium that include a first “fast-acting” chromium complex and a second “slow-acting” chromium complex, wherein the first chromium complex is absorbed more quickly than the slow-acting chromium complex, and methods of using the same. Also provided herein are methods for treating, preventing, and improving conditions associated with cardiometabolic syndrome, by identifying a subject in need of treatment, prevention, or improvement of a condition associated with cardiometabolic syndrome, and providing a therapeutically effective amount of a composition comprising a fast-acting chromium complex and a slow-acting chromium complex, to the individual.

Claims

1. A method of treating a condition associated with insulin resistance comprising:

administering a therapeutically effective amount of chromium to a patient having a condition associated with insulin resistance, the therapeutically effective amount of chromium provided in a first amount of chromium in the form of a lipophilic chromium complex and a second amount of chromium provided in the form of a hydrophilic chromium complex, wherein the first and second amounts are selected to have a greater than additive effect on the treatment of the condition than the effect of the administration of chromium in the form of lipophilic chromium complex alone plus the effect of the administration of chromium in the form of hydrophilic chromium complex alone, wherein the molar ratio of chromium in said hydrophilic chromium complex to chromium in said lipophilic chromium complex is between about 1;

10 and 10;

1.

2. The method of claim 1, wherein the patient has been diagnosed with polycystic ovarian syndrome.

3. The method of claim 1, wherein the molar ratio of chromium in said hydrophilic chromium complex to chromium in said lipophilic chromium complex is between about 1:

2 and 2;

1.

4. The method of claim 1, wherein said hydrophilic chromium complex is selected from the group consisting of chromium acetate, chromium chloride, chromium histidinate, and combinations thereof.

5. The method of claim 1, wherein said hydrophilic chromium complex consists essentially of a chromium histidinate complex.

6. The method of claim 1, wherein said hydrophilic chromium complex is selected from the group consisting of chromium and histidine, a chromium histidinate complex, and combinations thereof.

7. The method of claim 1, wherein said lipophilic chromium complex is selected from the group consisting of chromium picolinate, chromium tripicolinate, and combinations thereof.

8. The method of claim 1, wherein said lipophilic chromium complex is chromium picolinate.

9. The method of claim 1, wherein the patient has been diagnosed with hyperglycemia.

10. The method of claim 1, wherein the patient has been diagnosed with obesity.

11. The method of claim 1, wherein the patient has been diagnosed with Alzheimer'"'"'s disease.

12. The method of claim 1, wherein the patient has been diagnosed with hypertension.

13. A method for administering chromium over a period of time to a subject comprising:

providing, to the subject, a therapeutically effective amount of chromium in a synergistic ratio of a hydrophilic chromium complex to a lipophilic chromium complex, wherein the synergistic ratio is a molar ratio between 1;

2 and 2;

1; and

wherein the synergistic ratio provides bioavailable chromium to the subject over a longer period of time than providing the same amount of chromium provided as a hydrophilic chromium complex alone and a lipophilic chromium complex alone.

14. The method of claim 13, wherein the therapeutically effective amount of chromium in synergistic ratio of a hydrophilic chromium complex to a lipophilic chromium complex provides a glucose lowering effect or glucose stabilization effect for at least 10 hours.

15. A method for reducing free fatty acid levels in a subject in need thereof,

comprising:

co-administering to said subject a therapeutically effective amount of a synergistic ratio of chromium provided in the form of a hydrophilic chromium complex to chromium provided in the form of a lipophilic chromium complex;

wherein the hydrophilic chromium complex is selected from the group consisting of chromium acetate, chromium chloride, chromium histidinate, chromium nicotinate, and combinations thereof, the lipophilic chromium complex is chromium picolinate, and the synergistic ratio is between about 1;

2 and 2;

1.

16. A method for treating dyslipidemia in a subject in need thereof, comprising:

co-administering to said subject a therapeutically effective amount of a synergistic ratio of chromium provided in the form of a hydrophilic chromium complex to chromium provided in the form of a lipophilic chromium complex;

wherein the hydrophilic chromium complex is selected from the group consisting of chromium acetate, chromium chloride, chromium histidinate, chromium nicotinate, and combinations thereof, the lipophilic chromium complex is chromium picolinate, and the synergistic ratio is between about 1;

2 and 2;

1.