Development and Evaluation of Pediatric Orally Disintegrating Paracetamol Tablets

Abstract

The limitations of commercially available paracetamol formulations specifically: 1) stability and portability (commercial paracetamol suspensions) and 2) non-pediatric friendly excipients and expensive manufacturing processes (commercially available paracetamol orally disintegrating tablets) 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.