Design and Evaluation of Delayed Release Enteric Coated Tablets of Tenetoprazole

The Present study was undertaken with an aim to formulate delayed release enteric coated tablets of Tenatoprazole to avoid the degradation in stomach, as it is an acid labile drug and to improve bioavailability. The method adopted for development was direct compression. Different core tablets were prepared by using approved excipients and evaluated for parameters like hardness, friability, thickness and disintegration time. Sub coating was done for the optimized formulation (F5) by using Hydroxy propyl methyl cellulose 5cps with buildup of 3%w/w and finally enteric coating was done by using polymers like Hydroxy propyl methyl cellulose phthalate (HPMCP), Eudragit L30 D55 and Hydroxy propyl methyl cellulose acetate succinate (HPMCAS) with an average weight build up of 5%, 8% & 10% w/w. All the formulations were evaluated for their physicochemical parameters and compared with marketed sample. Results indicated that all the tablets prepared possess good integrity, desirable for enteric coated tablets. At the end it was found that prepared formulation gave satisfactory results compared with market sample dissolution profile. Among the polymers studied, the methacrylic acid polymers exhibited better dissolution rate than the cellulose polymers. The selected formulation (F5h with 8% w/w) was subjected for stability studies as per ICH guidelines and were found to be stable, as no significant change was observed in the evaluated parameters. Hence prepared formulation by-pass the degradation of Tenatoprazole by enteric coating and thus a pharmaceutically equivalent, robust formulation of Tenatoprazole enteric coated tablet was developed.