Patent ID: 9717701
Date: 2017-08-01
CPC Classifications: A61K,A61P

Claim:
1. A sustained release oral solid dosage formulation consisting of O-desmethyltramadol or a pharmaceutically acceptable salt thereof homogenously dispersed in a sustained release matrix delivery system in the form of a tablet or capsule, wherein the sustained release matrix system consists 10-90 wt % of a polymer selected from polysaccharide, acrylic resin, polyalkylene glycol, polyvinyl acetate, polyvinylpyrrolidone, protein-derived materials and mixtures thereof, 25-90 wt % of microcrystalline cellulose; and, optionally, one or more pharmaceutical excipients selected from the group consisting of salts, colloidal silica, and magnesium stearate; wherein the sustained release matrix system provides an in vitro dissolution of between 15 and 74% O-desmethyltramadol released after 1 hour and between 79 and 105% O-desmethyltramadol released after 12 hours measured using the USP Apparatus I Basket Method at 75 rpm in 900 ml 0.05 M phosphate buffer with a pH 7.2 at 37° C., and upon administration to a human subject provides a controlled release of O-desmethyltramadol over at least about 8 hours.