| 摘要 |
A sustained-release oral dosage form containing one active agent selected from the group consisting of oxycodone and an oxycodone salt, the dosage form comprising: (a) a bilayer core comprising: (i) a drug layer comprising an analgesically effective amount of oxycodone or oxycodone salt; and (ii) a displacement layer or a push layer comprising an osmopolymer and an osmagent selected from the group consisting of sodium chloride, potassium chloride, magnesium sulphate, lithium phosphate, lithium chloride, sodium phosphate, sodium sulphate, potassium phosphate, glucose, fructose and maltose; and (b) a semipermeable wall surrounding the bilayer core having a passageway disposed therein for the release of said oxycodone or oxycodone salt; said dosage form providing an analgesic effect at least about 24 hours after steady-state oral administration to human patients; and a mean C24/Cmax oxycodone ratio of 0.6 to 1.0. The use of this dosage form for the preparation of a pharmaceutical composition for the treatment of pain. |
