Abstract

Formulation and evaluation of enteric coated tablets of proton pump inhibitor

The present study was an attempt to formulate and evaluate enteric coated tablets for esomeprazole magnesium trihydrate. Different core tablets were prepared and formulation (F-1) was selected for further enteric coating, based on the disintegra-tion time. Seal coating was applied to achieve 3% weight gain using opadry®. Enteric coating was carried out using different polymers like Eudragit L-30 D-55, hydroxy pro-pyl methylcellulose phthalate, cellulose acetate phthalate and Acryl-EZE® to achieve 5% weight gain. Disintegration studies showed that the formulations failed in 0.1 N HCl media. Hence the quantity of enteric coating was increased to 8% w/w. In vitro analysis of the developed tablets was carried out. Results from disintegration time and dissolution rate studies indicate that all the esomeprazole enteric tablets prepared pos-sess good integrity, desirable for enteric coated tablets. Among the polymers studied, the methacrylic polymers exhibited better dissolution rate than the cellulose polymers. Stability studies indicate that the prepared formulations were stable for a period of three months. This study concluded that enteric coated tablets of esomeprazole can be prepared using any of the enteric coating polymer studied using a minimal weight gain of 8%.