Composition comprising clay mineral complex for prevention, alleviation, and treatment of inflammatory bowel disease, preparation method for composition, and method for alleviation and treatment for inflammatory bowel disease

Patent metadata

Field	Value
Publication number	US-12409169-B2
Application number	US-201917603093-A
Country	US
Kind code	B2
Filing date	Dec 17, 2019
Priority date	Apr 12, 2019
Publication date	Sep 9, 2025
Grant date	Sep 9, 2025

Abstract

The present invention relates to a pharmaceutical composition for prevention, alleviation, and treatment of inflammatory bowel disease, the composition comprising a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof and a clay mineral; a method for prevention, alleviation, and treatment of inflammatory bowel disease by using same; and a preparation method of the pharmaceutical composition.

First claim

The invention claimed is:

1. A pharmaceutical composition for treatment of inflammatory bowel disease, comprising a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral:

2. The pharmaceutical composition of claim 1 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is 2 to 10 times longer than a time t max to reach maximum plasma concentration during oral administration of an aqueous solution of the compound of Chemical Formula 1.

3. The pharmaceutical composition of claim 1 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is longer than a time to reach maximum plasma concentration (t max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

4. The pharmaceutical composition of claim 1 , wherein a maximum plasma concentration (C max ) during oral administration of the composition is 20% to 80% of a maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

5. The pharmaceutical composition of claim 1 , wherein the maximum plasma concentration (C max ) during oral administration of the composition is lower than the maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

6. The pharmaceutical composition of claim 1 , wherein an alleviation effect of a drug on a symptom selected from the group consisting of inflammation, crypt cell damage, ulcer, edema and fibrosis in a large intestine of the compound of Chemical Formula 1 during oral administration of the composition is higher than the alleviation effect of the drug in the large intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

7. The pharmaceutical composition of claim 1 , wherein an absorption rate in a small intestine of the compound of Chemical Formula 1 during oral administration of the composition is lower than the absorption rate in the small intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

8. The pharmaceutical composition of claim 1 , wherein a dissociation rate when the complex is added to an eluate of pH 1.2 is slower than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 1.2.

9. The pharmaceutical composition of claim 1 , wherein a dissociation rate when the complex is added to an eluate of pH 7.4 is faster than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 7.4.

10. A preparation method of a pharmaceutical composition for treatment of inflammatory bowel disease, comprising preparing a complex by mixing a solution containing a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof, an acidic reaction solution, and a clay mineral suspension to adsorb the compound onto the clay mineral:

11. The preparation method of the pharmaceutical composition of claim 10 , wherein the pH of the reaction solution is pH 0.5 to pH 3.5.

12. A food composition for alleviation of inflammatory bowel disease, comprising a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral:

13. A method for treatment of inflammatory bowel disease, comprising administering a pharmaceutical composition including a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral to a subject in need thereof:

14. A method for alleviation of inflammatory bowel disease, comprising administering a pharmaceutical composition including a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral to a subject in need thereof:

15. The method for treatment of inflammatory bowel disease of claim 13 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is 2 to 10 times longer than a time to reach maximum plasma concentration (t max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

16. The method for treatment of inflammatory bowel disease of claim 13 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is longer than a time to reach maximum plasma concentration (t max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

17. The method for treatment of inflammatory bowel disease of claim 13 , wherein a maximum plasma concentration (C max ) during oral administration of the composition is 20% to 80% of a maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

18. The method for treatment of inflammatory bowel disease of claim 13 , wherein the maximum plasma concentration (C max ) during oral administration of the composition is lower than the maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

19. The method for treatment of inflammatory bowel disease of claim 13 , wherein an alleviation effect of a drug on a symptom selected from the group consisting of inflammation, crypt cell damage, ulcer, edema and fibrosis in a large intestine of the compound of Chemical Formula 1 during oral administration of the composition is higher than the alleviation effect of the drug in the large intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

20. The method for treatment of inflammatory bowel disease of claim 13 , wherein an absorption rate in a small intestine of the compound of Chemical Formula 1 during oral administration of the composition is lower than the absorption rate in the small intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

21. The method for treatment of inflammatory bowel disease of claim 13 , wherein a dissociation rate when the complex is added to an eluate of pH 1.2 is slower than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 1.2.

22. The method for treatment of inflammatory bowel disease of claim 13 , wherein a dissociation rate when the complex is added to an eluate of pH 7.4 is faster than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 7.4.

23. The method for treatment of inflammatory bowel disease of claim 13 , wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis.

Assignees

• Korea Inst Geoscience & Mineral Resources

Inventors

• Kang Il-Mo
• Lee Jangik Ike
• Kim Dae-Duk
• Kim Jae Hwan
• Roh Ki-Min
• Seo Sung Man
• Jung Su Young
• Park Ju-Hwan
• Baek Min-Jun
• Kim Gyu-Ho

Classifications

• A61K33/06

  Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} · CPC title

• A61K31/444

  containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone · CPC title

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title

• A61K9/0053 Primary

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title