Melt-extruded solid dispersions containing an apoptosis-inducing agent

US11369599B2 · kind B2 · utility

Assignees

• Abb Vie Inc. · US
• Abb Vie Deutschland Gmbh & Co. KG · DE

Inventors

• Esther Birtalan · Karlsruhe, DE
• Peter Hoelig · Wächtersbach, DE
• David Lindley · Antioch, US
• Yeshwant D. Sanzgiri · Gurnee, US
• Ping Tong · Potomac, US

Key dates

• Filing date: Jul 24, 2014
• Grant date: Jun 28, 2022
• Expiry date: Mar 12, 2035

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61P43/00
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

A pro-apoptotic solid dispersion comprises, in essentially non-crystalline form, a Bcl-2 family protein inhibitory compound of Formula I as defined herein, dispersed in a solid matrix that comprises (a) a pharmaceutically acceptable water-soluble polymeric carrier and (b) a pharmaceutically acceptable surfactant. A process for preparing such a solid dispersion comprises subjecting to elevated temperature the compound of Formula I, the water-soluble polymeric carrier and the surfactant, to provide an extrudable semi-solid mixture; extruding the semi-solid mixture; and cooling the resulting extrudate to provide a solid matrix comprising the polymeric carrier and the surfactant and having the compound dispersed in essentially non-crystalline form therein. The solid dispersion is suitable for oral administration to a subject in need thereof for treatment of a disease characterized by overexpression of one or more anti-apoptotic Bcl-2 family proteins, for example cancer or an immune or autoimmune disease.