Paras P. JAIN,Ajay Kumar SINGH,Praveen Kumar SUBBAPPA,Keerthi PRIYA,Girish Kumar JAIN,Girish G. KORE,Hanimi Reddy BAPATU,Sandeep JAIN
申请号：
US16774457
公开号：
US20200222395A1
申请日:
2020.01.28
申请国别(地区):
US
年份:
2020
代理人:
摘要：
Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.
