# US 11,026,916 B2 · Treatment for non-alcoholic fatty liver diseases

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- Number: US 11,026,916 B2
- Document ID: US11026916B2
- Status: Granted
- Kind: B2
- Application number: 16/453,934
- Filed: 2019-06-26
- Published: 2019-10-17
- Granted: 2021-06-08
- Earliest claimed: 2014-12-15
- Assignees: Dsm IP Assets B.V.
- Applicants: Dsm IP Assets B.V.
- Inventors: Szabolcs Peter; Joseph Schwager
- Web page: https://patentgrep.com/patent/US11026916B2

## CPC

- A61K 31/355: Tocopherols, e.g. vitamin E
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/15: Vitamins
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/22: of acyclic acids, e.g. pravastatin
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A23V 2250/1882: Polyunsaturated fatty acids
- A23V 2250/712: Vitamin E
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

Mixtures of vitamin E and polyunsaturated fatty acids (PUFAs) are provided as agents for the prevention, control and/or treatment of conditions associated with excessive fat accumulation in the liver which is not caused by alcohol abuse, including control and/or treatment of non-alcoholic steatosis in the liver—known as non-alcoholic fatty liver disease (NAFLD)—and/or non-alcoholic steatohepatitis (NASH) in a subject in need thereof.

## Claims

### Claim 1

A method of treating a condition requiring modulation of inflammatory response associated with accumulation of fat in the liver which is not caused by consumption/abuse of alcohol, which comprises administering to a patient in need thereof a composition comprising vitamin E and ω-3 docosahexaenoic acid (DHA), wherein the ratio of vitamin E to the DHA provides a synergistic effect and is in the range of about 1:1 to about 1:2, wherein the vitamin E is calculated as α-tocopherol, wherein the composition is administered as a daily dose of about 500 to about 2000 mg vitamin E and about 400 mg to about 4000 mg DHA, and wherein the inflammatory response is non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).

### Claim 2 (depends on 1)

The method according to claim 1, wherein the vitamin E is selected from the group consisting of α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol and mixtures thereof.

### Claim 3 (depends on 1)

The method according to claim 1 wherein the composition consists essentially of the vitamin E and the DHA.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the composition is administered in the form of a tablet, soft drink or gelatin capsule having hepatoprotective effect.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the composition further comprises at least one ingredient selected from the group consisting of water, vegetable oils, gelatin, lubricants, and cellulose.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the DHA comprises DHA ethyl ester.