COMPRESSION OF ENTERIC-COATED PELLETS TO DISINTEGRATING TABLETS

Enteric-coated sucrose pellets containing a layer of bisacodyl beneath the coating were compressed into tablets on an instrumented single-pu nch machine using four different filler-binders for direct compression . Different copolymers based on polymethacrylates were applied as coat ings. Pellets of two different crushing strengths were used. The quali ty of the films before and after tableting was evaluated by determinin g the amount of bisacodyl liberated after treatment for 2 h in 0.1 M H Cl according to the requirements of USP 23 for enteric-coated preparat ions. Results indicate that the most important parameters are the coat ing agent itself and the amount of coating applied to the pellets. Hig her coating weights and coatings with better elastic properties lead t o formulations, which liberate less bisacodyl after compression. Formu lations are available that fulfil all requirements of USP 23 regarding enteric-coated preparations.