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.

Keywords: Pediatric formulations, orally disintegrating tablets, paracetamol, drug delivery