Pharmaceutical compositions comprising 5-azacytidine monohydrate

摘要

Provided herein are pharmaceutical compositions or dosage forms comprising crystalline 5-azacytidine monohydrate. The pharmaceutical compositions or dosage forms provided herein may be used for oral administration in the treatment of diseases, including the treatment of myelodysplastic syndromes (MDS).

主权项

1. A solid pharmaceutical composition for oral administration comprising crystalline 5-azacytidine monohydrate substantially free of other solid forms of 5-azacytidine, and a pharmaceutically acceptable carrier, diluent, or excipient; wherein the composition is a capsule or a tablet, wherein the crystalline 5-azacytidine monohydrate is characterized by X-Ray Powder Diffraction peaks at the following approximate positions:2θ Angle (degree)6.56611.98313.08915.13817.44620.76221.04922.77624.36325.74326.30528.74131.39332.80633.04333.53636.37139.15741.643,and wherein the composition contains between about 5 mg and about 200 mg of 5-azacytidine.