Sustained release formulation of nalbuphine

A sustained release oral solid dosage form comprising nalbuphine or a pharmaceutically acceptable salt thereof in a gel matrix sustained release delivery system,

• wherein the dosage form provides a controlled release of the nalbuphine over a time period of at least about 8 hours, in the form of a tablet.

The dosage form of claim 75, wherein the sustained release delivery system comprises about 10 mg to about 420 mg.

A sustained release oral tablet comprising nalbuphine or a pharmaceutically acceptable salt thereof homogeneously dispersed in a sustained release delivery system selected from the group consisting of gums, cellulose ethers, acrylic resins, polyvinyl pyrrolidone, protein-derived compounds, and mixtures thereof, and at least one pharmaceutical diluent, the tablet providing a release of the nalbuphine over a time period of at least about 8 hours.

The sustained release oral tablet of claim 55, wherein the minimum blood serum level is not more than 20% below the mean blood serum level for all time points in the plateau.

A sustained release oral tablet, comprising from about 1 mg to about 200 mg nalbuphine or a pharmaceutically acceptable salt thereof in a sustained release matrix delivery system, the tablet providing an onset of nalbuphine effect from about 30 minutes of dosing to within about 6 hours of dosing and a duration of nalbuphine effect of at least 8 hours.