Twin-screw melt granulation for high-dose paracetamol tablets

In this study twin-screw melt granulation (TSMG) was used to produce sustained release formulations and improve the poor compressibility of paracetamol (PMOL). By using polyethylene glycol (PEG), a low melting point binder and ethyl cellulose (EC) as insoluble carrier, granules the formation of granules occurred at low processing temperatures (55oC). X-ray diffraction and differential scanning calorimetry analysis showed the presence of partially crystalline PMOL in the extruded granules. Compressed caplet tablets comprising of TSMG granules presented sustained release profiles for 3-4 h depending on the EC concentration. The tablets showed excellent tabletability and low compaction forces were applied. TSMG can be used for both poor compressibility actives and high-dose tablets.