| abstract |
The invention relates to a controlled release bead comprising: i) a microcrystalline cellulose core unit having a diameter of 100-2000 micron, preferably 710-1000 micron, which constitutes 50-90 wt%, preferably 70-90 wt%, of the total weight of the bead composition; ii) a water soluble coat surrounding said core unit and comprising a vinyl pyrrolidone polymer, preferably the water soluble coat surrounding said core unit constitutes 2-6 wt% of the total weight of the bead composition. iii) a drug layer comprising tolterodine or a pharmaceutically acceptable salt, preferably tolterodine tartate thereof and a pharmaceutical acceptable binder; and iv) a controlled release layer comprising a pH independent polymer, preferably a polyacrylate, to a process for preparing these beads, to a pharmaceutical dosage form, and to their use. |