Pharmaceutical compositions of Lurasidone

US11103503B2 · kind B2 · utility

Assignee

• Slayback Pharma LLC · US

Inventors

• Paras P. JAIN · Amravati, IN
• Ajay Singh · Princeton, US
• Praveen Kumar Subbappa · Princeton, US
• Keerthi Priya · Ghanpur, IN
• Girish Kumar Jain · Ashti, IN
• Girish G. Kore · Jamkhed, IN
• Hanimi Reddy Bapatu · Hyderabad, IN
• Sandeep Jain · Milpitas, US

Key dates

• Filing date: Jan 28, 2020
• Grant date: Aug 31, 2021
• Expiry date: Jan 28, 2040

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/146
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

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.