Pharmaceutical composition comprising refined indigo naturalis extract and the use thereof

Patent metadata

Field	Value
Publication number	US-10232006-B2
Application number	US-201715592911-A
Country	US
Kind code	B2
Filing date	May 11, 2017
Priority date	Apr 9, 2015
Publication date	Mar 19, 2019
Grant date	Mar 19, 2019

Abstract

A refined Indigo Naturalis extract or Indigo-producing plant extract containing at least 65% (w/w) an indirubin derivative based on total weight of active ingredients is described. Also described are a pharmaceutical composition containing the refined extract, and the use of the pharmaceutical composition for treating or alleviating a disease or condition.

First claim

The invention claimed is:

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.

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

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

4. 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.

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.

6. The pharmaceutical composition of claim 5 , comprising 0.002% to 0.077% (w/w) of the solid extract relative to the total weight of the pharmaceutical composition, and a pharmaceutically acceptable carrier comprising at least one of an oil, an emulsifier, a thickening agent, and a preservative.

7. 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.

8. 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.

9. 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.

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

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.

12. The topical pharmaceutical composition of claim 11 , comprising 0.002% to 0.077% (w/w) of the solid extract relative to the total weight of the pharmaceutical composition, and a pharmaceutically acceptable carrier comprising at least one of an oil, an antioxidant, an emulsifier, a thickening agent, and a preservative.

13. 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.

14. 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.

15. 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.

16. 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, pustular dermatosis, comprising administering to a subject in need thereof a pharmaceutical composition of claim 5 .

17. 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, pustular dermatosis, comprising topically administering to a subject in need thereof a pharmaceutical composition of claim 11 .

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

19. 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.

20. 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.

Assignees

• Galderma Sa

Inventors

• Chantalat Laurent
• Andres Philippe

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61P31/10

  Antimycotics · CPC title

• A61P17/00

  Drugs for dermatological disorders · CPC title

• A61P17/04

  Antipruritics · CPC title