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