Pellets with an active substance - matrix and a polymer coating, and a process for the production of the pellets

摘要

The present invention relates to active substance-containing pellets with polymer coating and an average particle size in the range from 300 to 1100 μm, comprising a pharmaceutically active substance, embedded in a polymer matrix of one or more polymers, characterized in that the pellets a friability of at most 0,1%, measured with 200 g of pellets to a screening machine with 200 μm screen, a screen diameter of 20 cm and 1,5 mm - shaking amplitude in the case of a vibrating - frequency of 50 1 / sec for 10 min in the presence of six rubber cubes with 1,8 cm edge length, and with a polymer coating is composed of an anionic (meth) acrylate - polymer are coated with the proviso that the pellets in the freely composition test according to u.s. pat. no. in synthetic gastric fluid at a ph of 1,2 according to 120 min is not more than 10% of the active compound release.