Patent No. EP4084778 (titled "Amorphous Kinase Inhibitor Formulations And Methods Of Use Thereof") was filed by Deciphera Pharmaceuticals on Dec 30, 2020. The application was issued on Nov 1, 2023.
This invention provides a pharmaceutically acceptable oral composition comprising one or more excipients and a solid dispersion. The solid dispersion consists of a pharmaceutically acceptable polymer (e.g., hydroxypropylmethylcellulose acetate succinate) and an amorphous form of a compound represented by Formula (I). The amorphous form is characterized by high purity (≥95% by HPLC), high amorphous content (>95% or >96% by weight), and stability against crystallization (≤5% crystalline form) under specific humidity and temperature conditions. The composition may be formulated as tablets featuring intragranular blends (containing the solid dispersion, fillers, disintegrants, glidants, and lubricants) and extragranular blends. It is intended for treating c-KIT and PDGFRα-driven malignancies, including GIST, glioblastoma, hypereosinophilic syndrome, and various sarcomas and carcinomas.

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