Polymorphs of Ribociclib mono succinate
AssigneeShilpa Meicare Limited
InventorsSriram Rampalli, Lav Kumar Upalla, Suryanarayan Cherukuvada, Chanti Babu Patneedi, Gopala Krishna Dasari, Vijaya Murali Mohan Rao Seshagiri
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Abstract
The present invention relates to novel crystalline and amorphous polymorphic forms of Ribociclib(1) mono succinate. (I) Said crystalline forms may be useful in the improved preparation of oral dosage forms for the treatment of cancer.
Claims6
Crystalline Ribociclib mono succinate Form-SRS-I characterized by X-ray powder diffraction pattern comprising characteristic 2θ° peaks at 9.0, 13.0, 15.2, 16.5, 17.3, 18.3, 20.0, 21.4, 21.6, 22.1, 23.6, 23.9 and 28.0±0.2 2θ°.
Crystalline Ribociclib mono succinate Form-SRS-I characterized by X-ray powder diffraction pattern comprising characteristic 2θ° peaks at 9.0, 13.0, 15.2, 16.5, 17.3, 18.3, 20.0, 21.4, 21.6, 22.1, 23.6, 23.9 and 28.0±0.2 2θ°, wherein the process for the preparation of Crystalline Ribociclib mono succinate Form-SRS-I comprises the steps of:
- a) dissolving succinic acid in first solvent;
- b) adding Ribociclib;
- c) concentrating the reaction mass;
- d) optionally adding second solvent followed by distillation;
- and
- e) isolate the crystalline Ribociclib mono succinate.
Dependencies are inferred from the claim text.