Extended release composition of 2-(2-Aminothiazol-4-yl)-N-[4-(2{[(2R)-2-hydroxy-2-phenylethyl] amino} ethyl) phenyl] acetamide

An extended release composition consisting of:

• mirabegron or a salt thereof;
• a release controlling agent wherein the release controlling agent consists of a non-polymeric hydrophobic excipient selected from the group consisting of glyceryl behenate, carnauba wax, cetyl alcohol, hydrogenated vegetable oil, hydrogenated castor oil and a mixture thereof;
• and
• a mixture consisting of a diluent, a binder, a surfactant, and an antioxidant
• wherein the release controlling agent is present in a concentration ranging from 0.5 to 50% by weight of the extended release composition;
• and
• wherein dissolution of mirabegron from the extended release composition is not less than 20% in 3 hours and not less than 50% in 7 hours when measured in vitro in USP Apparatus Type 2 (Paddle) using pH 6.8-phosphate buffer of 900 mL, at 100 rpm.