Development and evaluation of taste-masked paracetamol chewable tablets using a polymer and/or wax dispersion technique

Abstract

Chewable tablets are easy-to-use dosage formulations and widely applied in pediatric dosage forms. However, the chewable tablets have to disintegrate in the mouth before swallowing, which makes the chewable tablet dosage forms inappropriate for bitter active ingredients. In this study, a polymer (Eudragit® EPO) and/or wax (cetyl alcohol, stearic acid, or beeswax) dispersion technique has been used to overshadow the unpleasant taste of paracetamol. The chewable tablet made from Eudragit® EPO dispersion showed low disintegration and dissolution due to its low water solubility. While the wax or the mixture of cetyl alcohol and Eudragit® EPO-based tablets had fast disintegration (11.50–35.40 s) and the drug release were >90% in 45 min. The taste-masking study in human volunteers revealed that the chewable paracetamol tablets prepared from drug dispersion improved the taste of the paracetamol chewable tablets without wax/Eudragit® EPO dispersion. The mixture of cetyl alcohol and Eudragit® EPO dispersion could mask bitter taste better than those of cetyl alcohol. In conclusion, cetyl alcohol together with Eudragit® EPO could be efficiently used in the formulation of taste-masked paracetamol chewable tablets that complied with the United States Pharmacopeia standard.