Development and evaluation of pediatric orally disintegrating paracetamol tablets

The limitations of commercially available paracetamol formulations specifically are its stability and portability and, non-pediatric friendly excipients and expensive manufacturing processes; which were addressed by developing tablets made using generally regarded as safe (GRAS) status excipients and a direct compression process. The aim of this study was to develop pediatric orally disintegrating tablets of paracetamol. Pediatric orally disintegrating tablets with 60-mg and 120-mg paracetamol strengths which disintegrated in less than 30 seconds were successfully prepared by a simple cost effective direct compression process. Tablet disintegration rates were found to correlate well with tablet water absorption ratios and to a lesser extent with tablet wetting times. There was no correlation between tablet disintegration times and tablet mechanical and physical properties such as the tablet breaking force (hardness) or friability.