Composiciones farmacéuticas de pralsetinib

• Main Authors: Dipak GORDHAN, Gordon D. WILKIE, Lia ROGAL, Kimberly Jean MILLER, Shellie RIGBY-SINGLETON, Joshua WAETZIG, Csanad M. VARGA, Robert J. HARRIS, Debra L. MAZAIK, Aimee J. SPENCELEY, Ian A. BARKER, Lauren MACEACHERN
• Format: Patent
• Language: Spanish
• Published: 14.07.2023
• Subjects: CHEMISTRY; HETEROCYCLIC COMPOUNDS; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; METALLURGY; ORGANIC CHEMISTRY; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

La presente descripción se refiere a una composición farmacéutica que comprende 1) una dispersión sólida amorfa que comprende pralsetinib, o una sal farmacéuticamente aceptable de este; y un polímero hidrofílico farmacéuticamente aceptable; y 2) un par efervescente; y formas cristalinas de pralsetinib y sal de clorhidrato de pralsetinib, que son útiles como inhibidores selectivos de RET. La presente descripción también proporciona composiciones farmacéuticamente aceptables que comprenden las formas cristalinas y métodos de uso de dichas composiciones en el tratamiento de diversos trastornos. The present disclosure relates to pharmaceutical composition comprising 1) an amorphous solid dispersion comprising pralsetinib, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable hydrophilic polymer; and 2) an effervescent couple; and crystalline forms of pralsetinib and pralsetinib hydrochloride salt, which are useful as a RET selective inhibitors. The present disclosure also provides pharmaceutically acceptable compositions comprising the crystalline forms and methods of using said compositions in the treatment of various disorders.