A process for the manufacture of a pharmaceutical product

摘要

An orally administered sustained release dosage unit form containing morphine, or a pharmaceutically acceptable salt thereof, as active ingredient, which composition gives a peak plasma level at from 1.0 to 6 hours after administration. The morphine dosage form is suitable for once-a-day administration. It is preferably in the form of a capsule filled with pellets comprising morphine and a hydrophobic release control material such as a natural or synthetic wax or oil e.g. hydrogenated vegetable or castor oil. A process for the manufacture of pellets comprises mechanically working a mixture of a drug and a hydrophobic fusible carrier in a high speed mixture so as to form agglomerates, breaking the agglomerates to give controlled release seeds and continuing the mechanical working with the addition of a low percentage of the carrier or diluent.