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

Patent metadata

Field	Value
Publication number	US-9701636-B2
Application number	US-201414541284-A
Country	US
Kind code	B2
Filing date	Nov 14, 2014
Priority date	Nov 15, 2013
Publication date	Jul 11, 2017
Grant date	Jul 11, 2017

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 pharmaceutical composition comprising a crystalline Compound (I):

wherein the crystalline Compound (I) has an X-ray powder diffraction pattern comprising peaks at approximately 15.0, 18.1, 20.3, 22.9, 24.0, 24.2, 26.3, 26.8, 35.2, and 37.4° 2θ and a melting point at 175.8° C.±5%; and
wherein the pharmaceutical composition comprises less than 10% by weight of any other crystalline Compound (I).

2. The pharmaceutical composition of claim 1 , wherein the crystalline compound comprises less than 5% by weight of any other crystalline Compound (I).

3. A pharmaceutical composition comprising a crystalline Compound (I):

wherein the crystalline Compound (I) has an X-ray powder diffraction comprising peaks at approximately 15.0, 18.1, 20.3, 22.9, 24.0, 24.2, 26.3, 26.8, 35.2, and 37.4° 2θ and a melting point at 175.8° C.±5%; and
wherein the pharmaceutical composition comprises less than 10% by weight of amorphous Compound (I).

4. The pharmaceutical composition of claim 3 , wherein the crystalline compound comprises less than 5% by weight of amorphous Compound (I).

5. A crystalline Compound (I):

which has an X-ray powder diffraction pattern comprising peaks at approximately 15.0, 18.1, 20.3, 22.9, 24.0, 24.2, 26.3, 26.8, 35.2, and 37.4° 2θ and a melting point at 175.8° C.±5%; and
wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC.

6. The crystalline compound of claim 5 , wherein the crystalline Compound (I) is at least 99.6% pure as measured by HPLC.

7. The crystalline compound of claim 6 , wherein the crystalline Compound (I) is at least 99.7% pure as measured by HPLC.

8. The crystalline compound of claim 7 , wherein the crystalline Compound (I) is at least 99.8% pure as measured by HPLC.

9. The crystalline compound of claim 8 , wherein the crystalline Compound (I) is at least 99.9% pure as measured by HPLC.

10. The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable carrier.

11. An oral dosage form comprising a pharmaceutical composition of claim 1 .

Assignees

• Akebia Therapeutics Inc

Inventors

• Copp James Densmore
• Newman Ann W
• Luong Anne

Classifications

• A61K9/2054 Primary

  Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title

• A61P43/00

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

• A61P7/06

  Antianaemics · CPC title

• C07B2200/13

  Crystalline forms, e.g. polymorphs · CPC title

• A61K9/4866

  Organic macromolecular compounds · CPC title