Patent ID: 8642078
Filing Date: 2014-02-04
Classification: A61K,A61P

Abstract:
1. A sustained release pharmaceutical composition comprising: a) a coating comprising ethylcellulose and hydroxypropylmethyl cellulose (HPMC), with a viscosity in the range of 12 to 18 cP; and b) cores, wherein the cores consist of a homogenous blend of predetermined amounts of tolterodine or a salt thereof and microcrystalline cellulose, wherein the amount of tolterodine or a salt thereof is from 0.5 to 10% by weight of a core and wherein the cores are pellets made by extrusion and spheronisation or by direct rotor pelletization so as to be uniform in size and shape, and wherein, in a dissolution test of said sustained release pharmaceutical composition, 15 to 55% of tolterodine will be detected in solution after 2 hours, 30 to 80% in 3 hours, 40 to 90% in 4 hours, 60 to 99% in 8 hours and 85% or more in 16 hours, when subjected to dissolution test according to USP, using Apparatus 1 (rotating basket) at 100 rpm with 900 ml of phosphate buffer (50 mM) at pH 6.8 and 37° C.