ARZNEIMITTEL IN FORM VON KUEGELCHEN MIT HOHEM ARZNEISTOFFGEHALT UND VERFAHREN ZU IHRER HERSTELLUNG

摘要

A pharmaceutical composition in the form of beads which may be prepared by an extrusion-spheronization technique and contains more than 80% by weight drug. 1 to 15% by weight non-lipophilic binder-plasticizer, such as microcrystalline cellulose to achieve required plasticity for processing, 0.5 to 12% by weight of a starch-based excipient such as sodium starch glycolate or pregelatinized starch to control water/fluid distribution and thereby inhibit agglomeration during processing, and optionally a water-soluble binder such as hydrolyzed gelatin to make the final beads less friable. During processing a granulating agent such as ethanol/water may be added to improve blend properties and control during spheronization.