# US 10,117,854 B2 · Method for treating hepatic encephalopathy

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- Number: US 10,117,854 B2
- Document ID: US10117854B2
- Status: Granted
- Kind: B2
- Application number: 15/935,695
- Filed: 2018-03-26
- Published: 2018-08-02
- Granted: 2018-11-06
- Earliest claimed: 2016-07-29
- Assignees: Medday Pharmaceuticals
- Applicants: Medday Pharmaceuticals
- Inventors: Frédéric Sedel
- Web page: https://patentgrep.com/patent/US10117854B2

## CPC

- A61K 31/4188: condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
- A23L 33/15: Vitamins
- 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)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- 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
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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

A method of treating or preventing type C Hepatic Encephalopathy in a human patient diagnosed with cirrhosis by administering a composition containing at least 200 mg biotin to the human patient daily.

## Claims

### Claim 1

A method of treating or reducing onset of symptoms of type C Hepatic Encephalopathy in a human patient diagnosed with cirrhosis, comprising administering a composition comprising at least 200 mg biotin to said human patient daily.

### Claim 2 (depends on 1)

The method of claim 1, wherein the type C Hepatic Encephalopathy is a persistent type C hepatic encephalopathy.

### Claim 3 (depends on 1)

The method of claim 1, wherein the type C Hepatic Encephalopathy is an episodic type C hepatic encephalopathy.

### Claim 4 (depends on 1)

The method of claim 1, wherein the type C Hepatic Encephalopathy is a minimal type C hepatic encephalopathy.

### Claim 5 (depends on 1)

The method of claim 1, wherein symptoms of Hepatic Encephalopathy in the human patient are decreased after the administration.

### Claim 6 (depends on 1)

The method of claim 1, wherein the daily amount of biotin administered to the patient is at least 250 mg.

### Claim 7 (depends on 1)

The method of claim 1, wherein the daily amount of biotin administered to the patient is at least 300 mg.

### Claim 8 (depends on 1)

The method of claim 1, wherein the patient has no clinical sign of Hepatic Encephalopathy before the administration.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition is in a form suitable for oral administration.

### Claim 10 (depends on 9)

The method of claim 9, wherein the form suitable for oral administration comprises at least one unit dosage form, wherein each unit dosage form contains at least 20 mg of biotin.

### Claim 11 (depends on 1)

The method of claim 1, wherein the composition is in the form of capsules, tablets, lozenges or pills.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition contains biotin and excipients, without any other active ingredient.

### Claim 13 (depends on 12)

The method of claim 12, wherein the excipients are selected from the group consisting of talc, microcrystalline cellulose, lactose and mannose.

### Claim 14 (depends on 1)

The method of claim 1, wherein the composition is in a form suitable for injectable administration.

### Claim 15 (depends on 1)

The method of claim 1, wherein the composition is in the form of a slow release composition.

### Claim 16 (depends on 1)

The method of claim 1, wherein said treatment with biotin has a duration of at least 3 months.

### Claim 17 (depends on 1)

The method of claim 1, wherein the daily amount of biotin administered to the patient is above 3 mg/kg.

### Claim 18 (depends on 1)

The method of claim 1, further comprising the simultaneous, separate or sequential administration of a therapeutic amount of another drug against type C Hepatic encephalopathy.

### Claim 19 (depends on 18)

The method of claim 18, wherein said other drug is selected from the group consisting of Lactulose, lactitol, neomycin, metronidazole, rifaximin, and a combination of L-ornithine and L-aspartate.

### Claim 20 (depends on 1)

The method of claim 1, further comprising supplementing the patient's diet with a compound selected from the group consisting of branched-chain amino acids, zinc sulfate, zinc acetate and L-carnitine.
