Compositions and methods to regulate hormonal cascades in stress disorders

• US 10,588,890 B2
• Filed: 05/30/2018
• Issued: 03/17/2020
• Est. Priority Date: 05/30/2017
• Status: Active Grant

• Current Assignee: Biommunity, Inc.
• Original Assignee: Biommunity, Inc.
• Inventors: Emerson, Paul G.
• Primary Examiner(s): Ramachandran, Umamaheswari
• Application Number:
  US15/993,576
• Publication Number:
  US 20180344687A1
• Time in Patent Office: 657 Days
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: 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
• CPC Class Codes: A61P 25/30 for treating abuse or dependence
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

The invention is composition and methods that restore balance to the stress-related steroidal hormone cascade. Upon co-administration, the compounds of the invention restore balance to the cascade and promote or restore normal function in patients suffering from a disorder having a primary psychological stress component. The compositions include a selected combination of isoflavones, alpha lipoic acid, and L dopamine or a precursor thereof, and are preferably obtained from the natural sources disclosed herein. The uses of the invention include administration of the disclosed compositions to patients suffering from PTSD, fibromyalgia, endometriosis, and other disorders having a common chronic stress component.

Claims

1. A method to promote balance in a steroidal hormone cascade in a patient suffering from PTSD or fibromyalgia comprising coadministration of:

(1) an R(+) enantiomer of alpha lipoic acid

(2) a dopamine precursor derived from a Mucuna genus; and

(3) a plurality of at least four isoflavones having the formula;

2. The method of claim 1, wherein the plurality of the isoflavones where R1=H and R2=CH3and R1=OH and R2=CH3 are at least 40% of the combination.

3. The method of claim 1, wherein the plurality of isoflavones are derived from a red clover extract.

4. The method of claim 1, wherein the dopamine precursor is derived from seeds of the Mucuna Pruriens and is present in an amount between 2-6 mg.

5. The method of claim 1, wherein the Mucuna is a species selected from the group consisting andreana, aterrima, birdwoodina tutcher, ochinchinensis, cochinensis, deeringiana, gigantean, holtonii, monosperma, mutisiana, pruriens, pruriens f. hirsute, pruriens f. utilis, pruriens var., pruriens var. utilizes, sloanei, and urens, and combinations thereof.

6. The method of claim 1, wherein each of the alpha lipoic acid, the dopamine precursor, and the plurality of isoflavones and wherein the coadministration is oral delivery as a tablet.

7. The method of claim 1, wherein each of the alpha lipoic acid, the dopamine precursor, and the plurality of isoflavones are combined in a single dosage form having a content of the plurality of isoflavones of between 100-500 mg.

8. The method of claim 1, are combined in a single dosage form with a total isoflavone content comprised of a combination of biochanin A and formononetin of at least 240 milligrams.

9. The method of claim 1, having a total isoflavone content of at least 300 milligrams.

10. The method of claim 1, wherein the alpha lipoic acid is enriched to at least 85% of the R (+) enantiomer.

11. The method of claim 10, wherein the R (+) of the alpha lipoid acid is a sodium salt thereof.

12. The method of claim 1, further comprising a peripheral nervous system decarboxylase inhibitor.

13. The method of claim 1, further comprising composition B6.

14. The method of claim 1, wherein the dopamine precursor is an extract of Mucuna Pruriens and the plurality of isoflavones is contained in naturally occurring red clover.