# US 10,307,451 B2 · Phytoestrogen product of red clover and pharmaceutical uses thereof

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- Number: US 10,307,451 B2
- Document ID: US10307451B2
- Status: Granted
- Kind: B2
- Application number: 15/149,183
- Filed: 2016-05-09
- Published: 2017-09-21
- Granted: 2019-06-04
- Earliest claimed: 2010-02-15
- Assignees: Sinoveda Canada, Inc.
- Applicants: Sinoveda Canada Inc.
- Inventors: Yun Kau Tam; Yi-Chan James Lin; Brian Duff Sloley; Chih-Yuan Tseng
- Web page: https://patentgrep.com/patent/US10307451B2

## CPC

- A61K 36/48: Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)}
- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- G16H 50/50: for simulation or modelling of medical disorders
- G16C 20/30: Prediction of properties of chemical compounds, compositions or mixtures
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16C: COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE

## Abstract

The present invention provides compositions comprising optimized ratios of Red clover phytoestrogens as determined by a proprietary physiologically based pharmacokinetic and pharmacodynamic model. The compositions are useful for modulating, preventing or treating postmenopausal or climacteric symptoms, which include but are not limited to bone loss, bone remodeling, hot flushes and vaginal atrophy. The present invention also provides methods for modulating, preventing or treating postmenopausal or climacteric symptoms using the compositions disclosed herein.

## Claims

### Claim 1

A method of modulating one or more climacteric symptoms in a subject, comprising the step of administering to the subject in need thereof an effective amount of a composition comprising Biochanin A, genistein, formononetin and daidzein, wherein the composition comprises 80%-96% Biochanin A, 1%-12% genistein, 1%-5% formononetin and 1%-5% of daidzein, wherein the effective amount includes 1.0-6.0 mg of total isoflavones, and the composition is administered via a route to avoid first-pass gastrointestinal and hepatic effects, and to avoid colonic bacterial metabolism, wherein the climacteric symptoms are selected from the group consisting of:
a. hot flashes;
b. vaginal atrophy;
c. vaginal dryness;
d. diaphoresis;
e. night sweat;
f. urinary tract symptoms; and
g. sleep disturbance.

### Claim 2 (depends on 1)

The method of claim 1, wherein the composition includes 5 mg of Biochanin A, 0.104 mg of genistein, 0.087 mg of formononetin, and 0.071 mg of daidzein.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition includes a ratio of Biochanin A to genistein is about 48:1.

### Claim 4 (depends on 1)

The method of claim 1, wherein the composition includes a ratio of Biochanin A to formononetin is about 58:1.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition includes a ratio of Biochanin A to daidzein is about 70:1.

### Claim 6 (depends on 1)

The method of claim 1, wherein the composition is formulated as parenteral, buccal, sublingual, topical, transdermal or intra-vaginal dosage forms.

### Claim 7 (depends on 1)

The method of claim 1, wherein the composition is formulated as a dosage form for intramuscular, subcutaneous or intravenous administration.

### Claim 8 (depends on 1)

The method of claim 1, wherein the composition is formulated in the form of suppository, cream, injection, solution, or suspension.