Once-a-day oxycodone formulations

摘要

Disclosed is a sustained-release oral dosage form for once-a-day administration comprising: a pharmaceutically acceptable sustained-release matrix including (a) an analgesically effective amount of oxycodone or a pharmaceutically acceptable salt thereof in the range from 1 mg to 640 mg, and (b) a sustained release material comprising a mixture of (i) a C12-C36 aliphatic alcohol, (ii) a C8-C50 fatty acid, and (iii) a hydrophobic polymer in an effective amount to render the dosage form suitable for once-a-day oral administration as part of the matrix, the dosage form providing an analgesic effect for at least about 24 hours and a mean C24/Cmax oxycodone ratio of 0.7 to 0.99 after once-a-day steady state oral administration to human patients.