# US 2017/0304381 A1 · Pharmaceutical composition and the use thereof

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- Number: US 2017/0304381 A1
- Document ID: US20170304381A1
- Status: Published application
- Kind: A1
- Application number: 15/592,911
- Filed: 2017-05-11
- Published: 2017-10-26
- Earliest claimed: 2015-04-09
- Assignees: Galderma S.A.
- Applicants: Galderma S.A.
- Inventors: Laurent CHANTALAT; Philippe ANDRES
- Web page: https://patentgrep.com/patent/US20170304381A1

## CPC

- A61K 36/70: Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K 8/492: {having condensed rings, e.g. indol}
- A61K 8/4953: {containing pyrimidine ring derivatives, e.g. minoxidil}
- A61K 8/97: from algae, fungi, lichens or plants; from derivatives thereof
- 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 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 31/404: Indoles, e.g. pindolol
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 36/19: Acanthaceae (Acanthus family)
- A61K 36/315: Isatis, e.g. Dyer's woad
- A61K 36/48: Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/04: Antipruritics
- A61P 17/06: Antipsoriatics
- A61P 17/10: Anti-acne agents
- A61P 17/12: Keratolytics, e.g. wart or anti-corn preparations
- A61P 31/10: Antimycotics
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61Q 19/08: Anti-ageing preparations
- A61K 2236/00: Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K 2800/92: Oral administration
- 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
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

A pharmaceutical composition, as well as the use of composition in medical applications, are described.

## Claims

### Claim 1

A solid extract of Indigo Naturalis comprising, relative to the total weight of the extract:
65% to 90% (w/w) indirubin;
0.1-15% (w/w) indigo; and
0.01-5% (w/w) tryptanthrin.

### Claim 2 (depends on 1)

The solid extract of claim 1, comprising 0.1-5% (w/w) tryptanthrin relative to the total weight of the extract.

### Claim 3 (depends on 2)

The solid extract of claim 2, further comprising 0.1-5% (w/w) qingdainone relative to the total weight of the extract.

### Claim 4 (depends on 3)

The solid extract of claim 3, being micronized and comprising particles having a particle size of less than or equal to 30 μm in 99% of the particles.

### Claim 5

A pharmaceutical composition comprising a solid extract of Indigo Naturalis and a pharmaceutically acceptable carrier, wherein the solid extract comprises, relative to the total weight of the extract:
65% to 90% (w/w) indirubin;
0.1-15% (w/w) indigo; and
0.01-5% (w/w) tryptanthrin.

### Claim 6 (depends on 5)

The pharmaceutical composition of claim 5, comprising 0.002% and 0.077% (w/w) of the solid extract relative to the total weight of the pharmaceutical composition.

### Claim 7 (depends on 6)

The pharmaceutical composition of claim 6, wherein the solid extract comprises 0.1-5% (w/w) tryptanthrin relative to the total weight of the extract.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein the solid extract further comprises 0.1-5% (w/w) qingdainone relative to the total weight of the extract.

### Claim 9 (depends on 8)

The pharmaceutical composition of claim 8, wherein the solid extract is micronized and comprises particles having a particle size of less than or equal to 30 μm in 99% of the particles.

### Claim 10 (depends on 5)

The pharmaceutical composition of claim 5, wherein the composition is in the form for topical administration or oral administration.

### Claim 11

A topical pharmaceutical composition comprising a micronized solid extract of Indigo Naturalis and a pharmaceutically acceptable carrier, wherein the solid extract comprises, relative to the total weight of the extract:
65% to 90% (w/w) indirubin;
0.1-15% (w/w) indigo; and
0.01-5% (w/w) tryptanthrin.

### Claim 12 (depends on 11)

The topical pharmaceutical composition of claim 11, comprising 0.002% and 0.077% (w/w) of the solid extract relative to the total weight of the pharmaceutical composition.

### Claim 13 (depends on 12)

The topical pharmaceutical composition of claim 12, wherein the solid extract comprises 0.1-5% (w/w) tryptanthrin relative to the total weight of the extract.

### Claim 14 (depends on 13)

The topical pharmaceutical composition of claim 13, wherein the solid extract further comprises 0.1-5% (w/w) qingdainone relative to the total weight of the extract.

### Claim 15 (depends on 14)

The topical pharmaceutical composition of claim 14, wherein the solid extract comprises particles having a particle size of less than or equal to 30 μm in 99% of the particles.

### Claim 16 (depends on 5)

A method of treating a disease or condition selected from the group consisting of psoriasis, an inflammatory skin condition, onychomycosis, skin cancer, abnormal keratinization induced diseases, skin aging, and pustular dermatosis, comprising administering to a subject in need thereof a pharmaceutical composition of claim 5.

### Claim 17 (depends on 11)

A method of treating a disease or condition selected from the group consisting of psoriasis, an inflammatory skin condition, onychomycosis, skin cancer, abnormal keratinization induced diseases, skin aging, and pustular dermatosis, comprising topically administering to a subject in need thereof a pharmaceutical composition of claim 11.

### Claim 18 (depends on 17)

The method of claim 17, wherein the disease or condition is psoriasis, an inflammatory skin condition, onychomycosis, skin aging or pustular dermatosis.

### Claim 19 (depends on 18)

The method of claim 18, wherein the disease or condition is the inflammatory skin condition selected from the group consisting of atopic dermatitis (AD), eczema and superinfected skin.

### Claim 20 (depends on 17)

The method of claim 17, wherein the disease or condition is the abnormal keratinization induced disease selected from the group consisting of acne, ichtyosis and palmoplantar keratoderma.