Design, Development and Evaluation of Enteric Coated Tablets of Glimepiride
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The main objective of work was to develop pharmaceutically elegant and stable enteric coated tablet formulation for highly unstable drug in acidic environment using pH dependent polymer. Development of Enteric coated tablets were done for Controlled Release of drug. Coating was done by using methacrylic acid copolymer (Eudragit L 100). Characterization of Drug and Excipients was carried out including compatibility studies of drug and excipients. Solid dispersion of glimepiride was formulated using carrier PEG20000 was prepared by the Fusion method. Evaluation of Solid was carried out using suitable parameters like solubility, percentage yield, drug content, in-vitro drug release, FTIR and SEM. Further granules were formulated from the optimized batch of formulated SDs. Pre-compression studies of granules were carried out like Tapped density, Bulk density, Angle of repose, etc. of Granules. Four different batches were formulated of tablets. The tablets were evaluated for various parameters like weight variation, hardness, friability, thickness, disintegration and in-vitro drug release. For Dissolution studies, 7.4 phosphate buffer media was used. The optimized batch of tablets was further subjected to enteric coating using pan coating. Eudragit L100 was used as coating polymer and isopropyl alcohol, acetone and triethyl citrate were used as vehicle in solution. Eosine was used as colorant. The coating solution was prepared in three different concentrations viz., 1%, 2%, and 3%. The coating solution was sprayed on tablets using spray gun and after drying the tablets were evaluated for different parameters like in-vitro drug release and disintegration, Hardness, thickness, friability, drug content and weight variation. Here, as the tablet was enteric coated, 2 dissolution medias were used 7.4 phosphate buffer and 0.1 N HCl. Further Stability studies were carried out of optimized batch. Results obtained after the stability studies confirmed that prepared enteric coated tablets were stable at applied conditions and were complied with the initial results.
Solid dispersion, Tablets, Enteric coating, Eudragit L100, Stability studies.