Quality by Design (QbD) approach to optimize the formulation of Multiunit Particulate System (MUPS).

Abstract

The objective of this study was to develop and evaluate a MUPS formulation intended for treatment digestive tract ulcers.Work involves evaluation of different formulations of esomeprazole magnesium having enteric polymer and plasticizers to understand impact on dissolution. A three-factor, two-level, full factorial design was used to investigate the influence of Eudragit L 100 55, Diethyl phthalate and Polyethylene glycol 6000 of the coating composition on the response, i.e., dissolution. Eudragit L 100-55 and Diethyl phthalate had a significant influence on dissolution, while Polyethylene glycol 6000 within studied level showed nonsignificant impact. Graphical analysis from pare to chart and half normal plots, enabled identification of variables active on the selected responses. The optimized formulation comprised of Eudragit L-100-55: 46.42mg/tablet, Diethyl phthalate: 6.14mg/tablet and Polyethylene glycol 6000: 0.71mg/tablet showed acid resistance and a desired release of Esomeprazole magnesium. Gastro-resistant MUPS formulation has been successfully developed for Esomeprazole Magnesium.