TAMPER RESISTANT IMMEDIATE RELEASE CAPSULE FORMULATION COMPRISING TAPENTADOL

摘要

The invention is directed to an immediate release capsule which mitigates the abuse of Tapentadol or physiologically acceptable salt thereof by direct intravenous injection. The capsule comprises a tamper resistant formulation which when mixed with water and heated, results in a turbid, bubbling mixture that is not injectable with a standard insulin syringe.

主权项

1. A tamper resistant pharmaceutical capsule comprising a capsule filling and a capsule shell, wherein said capsule filling is encapsulated by said capsule shell and comprises:
(a) Tapentadol or a physiologically acceptable salt thereof in an amount within the range of from 10 mg to 400 mg, as equivalent weight relative to Tapentadol free base; and (b) a liquid excipient blend comprising a solvent, a surfactant, and a viscosity enhancer; wherein the capsule provides immediate release of Tapentadol or the physiologically acceptable salt thereof upon oral administration.