| abstract |
The solid dosage form comprises an analgesically effective amount of an opioid analgesic or a salt thereof coated with a release controlling agent or deposited in the matrix controlling the release of the drug, wherein the in vitro dissolution rate of the dosage form is measured at USP Paddle Method at 100 rpm in 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37 sup.onC, is between 12.5 and 42.5% (w / w) opioid released after 1 hour, between 25 and 65% (w / w) opioid released after 2 hours, between 45 and 85% (w / w) opioid released after 4 hours and more than 60% (w / w) opioid released after 8 hours, wherein the in vitro release rate is substantially pH independent and selected such that the maximum in vivo plasma opioid level obtained is between 2 and 6 hours after administration of the dosage form |