| abstract |
Disclosed is a sustained release oral pharmaceutical dosage form containing an active agent that is resistant to tampering and a method for its preparation. A composition comprising (a) at least (1) at least one polyethylene oxide having an approximate molecular weight of at least 1,000,000 based on rheological measurements, and (2) at least one active agent. And (b) molding the composition to form a sustained release matrix formulation, and (c) at least at a temperature that is at least the softening temperature of the polyethylene oxide of the sustained release matrix formulation. A method of preparing a sustained release solid oral pharmaceutical dosage form comprising at least a step of curing the sustained release matrix formulation comprising at least a curing step of exposing for about 1 minute, and a sustained release oral pharmaceutical dosage form. The active agent is preferably an opioid analgesic, particularly oxycodone hydrochloride. [Selection figure] None |