# US 11,439,593 B2 · Composition for treating onychomycosis

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- Number: US 11,439,593 B2
- Document ID: US11439593B2
- Status: Granted
- Kind: B2
- Application number: 16/766,822
- Filed: 2018-11-20
- Published: 2021-01-21
- Granted: 2022-09-13
- Earliest claimed: 2017-12-01
- Assignees: NCP NewCare Products GmbH
- Applicants: NCP NewCare Products GmbH
- Inventors: Volker Gustav Adolf Krainbring
- Web page: https://patentgrep.com/patent/US11439593B2

## CPC

- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 45/00: Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 17/00: Drugs for dermatological disorders
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to a novel pharmaceutically active composition which is able to permeate into the deeper layers of the skin and the keratin sheets of nails. The composition is a microemulsion comprising at least an alcohol ethoxysulfate, an ethoxylated glyceryl fatty acid ester, and an ethoxylated sorbitol or sorbitol anhydride fatty acid ester. The composition may optionally comprise further additives like emollients, substances for hardening a nail, or substances for enhancing nail growth. The composition is particularly suitable for treating fungal infections of the skin or nails, such as athlete's foot and onychomycosis. The composition is also suitable for treating inflammatory skin diseases, such as psoriasis and atopic eczema.

## Claims

### Claim 1

Pharmaceutical composition in the form of a microemulsion, comprising
(a) from about 2.0 to about 10.0% (w/w) of an alcohol ethoxysulfate;
(b) from about 5.0 to about 45.0% (w/w) of an ethoxylated glyceryl fatty acid ester; and
(c) from about 4.0 to about 25.0% (w/w) of an ethoxylated sorbitol or sorbitol anhydride fatty acid ester.

### Claim 2 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said alcohol ethoxysulfate is dodecyl alcohol ethoxysulfate.

### Claim 3 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said alcohol ethoxysulfate is present in the composition in an amount of 5% to 10.0% (w/w).

### Claim 4 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said ethoxylated glyceryl fatty acid ester is an ethoxylated glyceryl cocoate.

### Claim 5 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said ethoxylated glyceryl fatty acid ester is present in the composition in an amount of 5% to 20.0% (w/w).

### Claim 6 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said ethoxylated sorbitol or sorbitol anhydride fatty acid ester is a partial ester with oleic acid.

### Claim 7 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said ethoxylated sorbitol or sorbitol anhydride ester is present in the composition in an amount of 5% to 10.0% (w/w).

### Claim 8 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said composition has a pH of 2.5 to 6.5.

### Claim 9 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said composition is formulated for topical application.

### Claim 10 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said composition further comprises urea.

### Claim 11 (depends on 1)

A method for treating a fungal infection of the skin or nail comprising applying a pharmaceutical composition according to claim 1 to an area of skin or nail.

### Claim 12 (depends on 11)

The method according to claim 11, wherein said fungal infection of the nail is onychomycosis.

### Claim 13 (depends on 11)

The method according to claim 11, wherein said fungal infection of the skin is selected from the group consisting of ringworm, Tinea cruris, Tinea capitis and Tinea pedis.

### Claim 14 (depends on 1)

A method for treating an inflammatory skin disease comprising applying a pharmaceutical composition according to claim 1 to an area of skin.

### Claim 15 (depends on 14)

The method according to claim 14, wherein said inflammatory skin disease is psoriasis or atopic eczema.

### Claim 16 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said alcohol ethoxysulfate is sodium lauryl ether sulfate.

### Claim 17 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said ethoxylated glyceryl fatty acid ester is PEG-7 glyceryl cocoate.

### Claim 18 (depends on 1)

Pharmaceutical composition according to claim 1, wherein said ethoxylated sorbitol or sorbitol anhydride fatty acid ester is polysorbate 80.

### Claim 19 (depends on 1)

Pharmaceutical composition according to claim 1, comprising
(a) from about 2.0 to about 10.0% (w/w) sodium lauryl ether sulfate;
(b) from about 5.0 to about 45.0% (w/w) PEG-7 glyceryl cocoate; and
(c) from about 4.0 to about 25.0% (w/w) polysorbate 80.
