Orally administered unit dosage form with controlled release and process for preparing thereof

摘要

In the present invention there is disclosed an orally administered unit dosage form with controlled release containing as an active component morphine or a pharmaceutically acceptable salt thereof, being formed by a tablet or a capsule containing multiparticles and further containing a material for a controlled release and 10 mg to 500 mg of morphine or pharmaceutically acceptable salts thereof based on morphine sulfate, and providing a maximum level of the plasma morphine within the range of 1.0 to 6 hours after administration and maintaining the plasma level at a height, that provides tranquilization of pain for at least 24 hours, in which the tablets or the multiparticles contain 10 to 60 percent by weight morphine or pharmaceutically acceptable salt thereof, whereby the tablets contain pressed multiparticles or the capsules are filled with multiparticles, whereby in both the cases the multiparticles contain particles of morphine or a morphine salt within the particles size ranging from 0.1 mm to 3.0 mm. In the present invention there is also claimed a hydrophobic meltable carrier or a diluent being selected from a group comprising hydrogenated vegetable oil, hydrogenated castor oil, beeswax, carnauba wax, microcrystalline wax or glycerin monostearate. In the present invention there is further described a process for preparing such orally administered unit dosage forms with controlled release.