Patent ID: 7988998
Filing Date: 2011-08-02
Classification: A61K

Abstract:
1. A once daily oral pharmaceutical composition for controlled release of tramadol, comprising: a core comprising tramadol dispersed in a first controlled-release matrix comprising cross-linked high amylose starch, wherein the tramadol is present in the core in an amount from about 10 to about 70 weight-percent of the composition of the core, and a compression coat formed over the core and comprising tramadol dispersed in a mixture of polyvinyl acetate and polyvinylpyrrolidone at a weight ratio of about 8:2 such that the mixture comprises from about 30% to about 65% by weight of the coat, wherein the release of tramadol from the core is slower than the release of tramadol from the coat, wherein the composition, upon initial administration of one dose, provides an onset of analgesic effect within 2 hours, which analgesic effect continues for at least 24 hours after administration, and wherein the composition is a tablet.