| 摘要 |
In the present invention, there is disclosed a sustained-release oral dosage form for once-a-day administration comprising: a pharmaceutically acceptable matrix or a plurality of pharmaceutically acceptable matrices containing 5 to 640 mg of oxycodone or a pharmaceutically acceptable salt thereof and a sustained release material being selected from the group consisting of gums, alkyl celluloses, cellulose ethers, acrylic resinous, materials of proteinaceous origin, waxes, shellac and oils, whereby said medicamentous dosage form provides an in-vitro release rate, of oxycodone or a pharmaceutically acceptable salt thereof, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37 degC of from 0 percent to about 40 percent at 1 hour, from about 8 percent to about 70 percent at 4 hours, from about 20 percent to about 80 percent at 8 hours, from about 30 percent to about 95 percent at 12 hours, from about 35 percent to about 95 percent at 18 hrs, and greater than about 50 percent at 24 hours, wherein said dosage form provides a mean Ci24/Cimax oxycodone ratio of 0.7 to 1.0 after steady state oral administration to human patients. |
