Formulation and evaluation of bilayer matrix tablets of rosuvastatin calcium and glimipiride for type II diabetes mellitus
DOI:
https://doi.org/10.61096/ijpar.v10.iss3.2021.326-340Keywords:
Bilayer matrix tablet, Glimepiride, Rosuvastatin Calcium, sustained release, Box-behnken designAbstract
Theaim of the present work was to develop a bilayer matrix tablet for type II diabetes mellitus which contain Glimepiride sustained release layer and Rosuvastatin Calcium immediate release layer. Sustained release layer of Glimepiride was optimised using Box-behnkendesign, a common analytical method for quantitative combined drug estimation was employed and evaluated. Hydroxy propyl methyl cellulose and Ethyl cellulose were used as polymers inorder to get the sustained release profile over a period of 12 h. Tablets were evaluated for physical properties, drug content and in vitro drug release. The excipients used in this formulation did not alter physicochemical properties of drug as tested by FTIR. Stability of the formulation at 60 days in room temperature shows no significant variation in appearance, hardness, drug content and in vitro drug release. This formulation also exhibited the best fitted formulation in zero order kinetics and non-Fickian transport. Bilayer tablet prepared from the optimised formula was found to be best suited method for fixed dose combination of sustained release Glimepiride and immediate release Rosuvastatin Calcium for type II diabetes mellitus.