Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof

Patent metadata

Field	Value
Publication number	US-11065237-B2
Application number	US-202016786187-A
Country	US
Kind code	B2
Filing date	Feb 10, 2020
Priority date	Nov 15, 2013
Publication date	Jul 20, 2021
Grant date	Jul 20, 2021

Abstract

Provided herein are solid forms comprising {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders.

First claim

What is claimed is:

1. A crystalline Compound (I):

which has an X-ray powder diffraction pattern comprising peaks at approximately 18.1, 20.3, 22.9, 24.0, and 26.3±0.2°2θ;
wherein the crystalline Compound (I) is anhydrous and unsolvated; and
comprises less than 10% by weight of any other amorphous or crystalline forms of Compound (I).

2. The crystalline Compound (I) of claim 1 , comprising less than 5% by weight of any other amorphous or crystalline form of Compound (I).

3. The crystalline Compound (I) of claim 2 , wherein the crystalline compound comprises less than 100 ppm of a compound of Formula (II),

as determined by GC/MS.

4. The crystalline Compound (I) of claim 3 , wherein the crystalline compound comprises less than 50 ppm of a compound of Formula (II).

5. The crystalline Compound (I) of claim 4 , wherein the crystalline compound comprises less than 10 ppm of a compound of Formula (II).

6. The crystalline Compound (I) of claim 5 , wherein the crystalline compound comprises less than 1 ppm of a compound of Formula (II).

7. The crystalline Compound (I) of claim 2 , wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC.

8. The crystalline Compound (I) of claim 7 , wherein the crystalline Compound (I) is at least 99.6% pure as measured by HPLC.

9. The crystalline Compound (I) of claim 8 , wherein the crystalline Compound (I) is at least 99.7% pure as measured by HPLC.

10. The crystalline Compound (I) of claim 9 , wherein the crystalline Compound (I) is at least 99.8% pure as measured by HPLC.

11. The crystalline Compound (I) of claim 10 , wherein the crystalline Compound (I) is at least 99.9% pure as measured by HPLC.

12. A pharmaceutical composition comprising a crystalline Compound (I) of claim 1 .

13. A pharmaceutical composition of claim 12 , further comprising a pharmaceutically acceptable carrier.

14. An oral dosage form comprising the crystalline Compound (I) of claim 1 .

15. A method for treating anemia, comprising administering a crystalline Compound (I) of claim 1 to a patient having anemia.

16. A method for treating anemia, comprising administering a pharmaceutical composition of claim 13 to a patient having anemia.

17. The method of claim 15 , wherein the anemia is anemia of chronic kidney disease.

18. The method of claim 16 , wherein the anemia is anemia of chronic kidney disease.

Assignees

• Akebia Therapeutics Inc

Inventors

• Copp James Densmore
• Newman Ann W
• Luong Anne

Classifications

• C07D213/81 Primary

  Amides; Imides · CPC title

• C07B2200/13

  Crystalline forms, e.g. polymorphs · CPC title

• A61P7/06

  Antianaemics · CPC title

• A61K31/4418

  having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine · CPC title

• C07D221/00

  Heterocyclic compounds containing six-membered rings having one nitrogen atom as the only ring hetero atom, not provided for by groups C07D211/00 - C07D219/00 · CPC title