Twin-screw melt granulation for high-dose paracetamol tablets

Abstract

Abstract Objectives In this study twin-screw melt granulation (TSMG) was used to produce sustained release formulations and improve the poor compressibility of paracetamol (PMOL). Methods By using various amounts of polyethylene glycol (PEG), a low melting point binder and ethyl cellulose (EC) as insoluble carrier, the formation of high content of PMOL granules occurred at low processing temperatures (55°C). Key findings 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. Conclusions TSMG can be used for the processing of drugs with poor compressibility actives for the compression of high-dose tablets.