Fulvestrant formulations and methods of their use

US11590077B2 · kind B2 · utility

Assignee

• Eagle Pharmaceuticals, Inc. · US

Inventors

• Feng-Jing Chen · New York, US
• Steven L. Krill · San Clemente, US
• Rama Abu Shmeis · Via Antonio Gattin, US
• Adrian HEPNER · Ramsey, US
• Charles Wescott · Woodcliff Lake, US
• Tara Jaskowski · Woodcliff Lake, US
• Michael A. Joyce · Edmonton, CA

Key dates

• Filing date: Nov 8, 2018
• Grant date: Feb 28, 2023
• Expiry date: Feb 13, 2039

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K47/32
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The present disclosure provides methods of treating breast cancer including administering aqueous suspensions comprising solubilized fulvestrant, non-solubilized fulvestrant particles having one or more of an LD Dv(10) between about 1.5 and about 2.1 microns, an LD Dv(50) between about 5.5 and about 9.0 microns, and an LD Dv(90) between about 15 and about 35 microns, with the aqueous suspensions further including a surfactant, a polyvinylpyrrolidone, and a sugar alcohol, and a water-soluble excipient. The water-soluble excipient can be an aryl-Ci-6alk-OH, a Ci-6alkyl-OH, a buffering salt, a polysorbate, a polyalkylene glycol, a Ci-i2alkylene glycol, a phosphatidylcholine, or a combination thereof.