Patent ID: 7931915

Claim:
A controlled release composition for oral administration comprising an extended release pellet wherein the extended release pellet comprises: (i) a core comprising: (a) 30-80% of a pharmaceutically acceptable salt of venlafaxine or its o-desmethylvenlafaxine active metabolite; (b) 1-20% of a binder; and (c) 20-70% of a sugar starting pellet (ii) a coating surrounding the core comprising a water insoluble polymer selected from the group consisting of polymethacrylate, methacrylic acid copolymers, methacrylate ester copolymers, acrylic acid, cellulose esters, cellulose ethers, cellulose ester-ethers or mixtures thereof and wherein the maximum plasma concentration of venlafaxine or o-desmethylvenlafaxine active metabolite is obtained in about one to four hours after administration of the controlled release composition when administered in a single dose study under fasting conditions and the controlled release composition exhibits the following dissolution profile when tested according to USP 26 with a Type 2 Apparatus at 50 rpm in distilled water at 37° C.: 0-55% of the venlafaxine or o-desmethylvenlafaxine is released after one hour; 20-60% of the venlafaxine or o-desmethylvenlafaxine is released after four hours; 25-80% of the venlafaxine or o-desmethylvenlafaxine is released after eight hours; and not less than 50% of the venlafaxine or o-desmethylvenlafaxine is released after twenty four hours.