Patent ID: 6645527
Filing Date: 2003-11-11
Classification: A61K,A61P

Abstract:
A stabilized sustained release oral solid dosage form containing tramadol as the active agent, comprisingan effective amount of tramadol or a pharmaceutically acceptable salt thereof dispersed in a matrix of a hydrophobic material comprising a substance which was melted or softened during the preparation of said matrix, said solid dosage form being cured at a temperature from about 35Â° C. to about 65Â° C. for a sufficient time such that an endpoint is reached at which said solid dosage form provides a stable dissolution profile, said endpoint being determined by comparing the dissolution profile of said solid dosage form immediately after curing to the dissolution profile of said solid dosage form after exposure to accelerated storage conditions of at least one month at 40Â° C. and 75% relative humidity.