Crystalline forms of an orally available, selective kit and PDGFR kinase inhibitor
AssigneeSandoz Ltd.
InventorsVerena Adamer, Andrea Thaler, Erwin Schreiner
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Abstract
The present invention relates to crystalline avapritinib, polymorphs and hydrates thereof as well as to processes for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising crystalline avapritinib and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment of patients with gastrointestinal stromal tumors (GIST) and advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL).
Claims15
Avapritinib according to the chemical structure as depicted in Formula (I)
- characterized in that said avapritinib is crystalline,
- wherein said crystalline avapritinib is in crystalline Form B, and said crystalline Form B is characterized by having a powder X-ray diffractogram comprising reflections at 2-Theta angles of (3.6±0.2)°, (16.0±0.2)° and (14.6±0.2)°, when measured at a temperature in the range of from 20 to 30° C. with Cu-Kalpha1,2 radiation having a wavelength of 0.15419 nm.
Dependencies are inferred from the claim text.