Crystalline forms of a prolyl hydroxylase inhibitor
The present disclosure relates to crystalline solid forms of [(4-hydroxy-1-methyl-7-phenoxy-isoquinoline-3-carbonyl)-amino]-acetic acid, the process of preparing the forms, and pharmaceutical compositions and methods of use thereof.
1. A pharmaceutical composition comprising crystalline [(4-hydroxy-1-methyl-7-phenoxy-isoquinoline-3-carbonyl)-amino]-acetic acid (Compound A Form A) characterized by an X-ray powder diffractogram comprising the following peaks: 8.5, 16.2, and 27.4° 2θ±0.2° 2θ, and a pharmaceutically acceptable excipient, wherein at least about 85% of Compound A is in Form A.
2. The pharmaceutical composition of claim 1 , wherein at least about 90% of Compound A is in Form A.
3. The pharmaceutical composition of claim 1 , wherein at least about 95% of Compound A is in Form A.
4. The pharmaceutical composition of claim 1 , wherein at least about 99% of Compound A is in Form A.
5. The pharmaceutical composition of claim 1 , wherein at least about 99.5% of Compound A is in Form A.
6. The pharmaceutical composition of claim 1 , wherein at least about 99.9% of Compound A is in Form A.
7. The pharmaceutical composition of claim 1 , wherein at least about 99.99% of Compound A is in Form A.
8. The pharmaceutical composition of claim 1 , wherein the diffractogram further comprises peaks at 12.8, 21.6, and 22.9° 2θ±0.2° 2θ.
9. The pharmaceutical composition of claim 1 , wherein the diffractogram is substantially as shown in FIG. 1 .
10. The pharmaceutical composition of claim 1 , wherein the Compound A Form A is characterized by a differential scanning calorimetry (DSC) curve that comprises an endotherm at about 223° C.
11. The pharmaceutical composition of claim 10 , wherein the DSC curve is substantially as shown in FIG. 2 .