Patent ID: 8895061

Claim:
A controlled release pharmaceutical formulation suitable for oral administration, comprising carisoprodol or a pharmaceutically acceptable, salt or ester thereof, and a pharmaceutically acceptable matrix adapted to provide a controlled release of carisoprodol or a pharmaceutically acceptable, salt or ester thereof upon oral administration, said controlled release pharmaceutical formulation having a dissolution rate in vitro when measured using Apparatus 2 (paddle) described in USP 30 at 65 rpm in 1000 ml of 0.1N hydrochloric acid from 0 hours to 12 hours of dissolution at 37.0±0.5° C. and using high performance liquid chromatography (HPLC) for quantification: between 25 and 70% carisoprodol released in 30 minutes; between 40 and 80% carisoprodol released in 1 hour; between 60 and 90% carisoprodol released in 2 hours; greater than 70% carisoprodol released in 4 hours; greater than 85% carisoprodol released in 8 hours; and greater than 95% carisoprodol released in 12 hours, by weight of the label claim, wherein said carisoprodol or a pharmaceutically acceptable derivative, salt or ester thereof has a particle size such that either (a) about 100% of the particles have an average size of less than about 50 microns; or (b) greater than about 40% of the particles are about 250 microns or greater.