EP3065718A1 — Controlled-release formulations comprising torsemide

USPTO Abstract

Disclosed herein are controlled-release (GR, e.g., extended-release (ER) or prolonged- release (PR)) oral dosage formulation comprising an effective amount of Torsemide or a pharmaceutically acceptable salt thereof and at least one sustained release excipient comprising a polymer, wherein the at least one matrix component is selected from the group consisting of: hydroxy propyl cellulose (HPC), hydroxpropyl methyl cellulose (HPMC), glyceryl behenate, and a polyethylene glycol glyceride. Torsemide may be present in the formulation in a range of about 1 wt% to about 20 wt%, or about 5 wt% to about 10 wt% and the matrix component is present in the formulation in a range of about 5 wt% to about 50 wt%, or about 15 wt% to about 35 wt%. The formulation may further comprise at least one binder, lactose, talc and magnesium stearate. Methods of making and using the controlled-release oral dosage Torsemide formulation are also disclosed. A novel mechanism for Torsemide action in diuresis is further disclosed.