FORMULATION AND EVALUATION OF BILAYER TABLET OF ATORVASTATIN AND PIOGLITAZONE FOR METABOLIC DISORDER Syed

The aim of the present study is to develop bilayered tablets of Atorvastatin and Pioglitazone which contains an immediate release layer and a sustained release layer of both the drugs for the effective treatment of metabolic disorder such as hyper lipidemia, type 2 diabetes milites and atherosclerosis. Croscarmellose sodium, and Crospovidone were used as super disintegrants along with Guggul gum in the immediate release layer (IR) and Ethyl Cellulose and Guar gum were used as release retardants for sustained release (SR). FTIR studies indicated there is no interaction between the drug, polymers, binders and other excipients. The pre compression parameters for IR &SR layer (F5) found as follow bulk density, (0.79 & 0.28), tapped density (0.88 & 0.29), Carr’s index (10.81 & 18.56) and Hausner’s ratio (1.15 & 1.12) and angle of repose (27.9) & (27.6) for the granules of both the layers which were within the limits of IP. The hardness (kg/cm2) of optimized formulation was found to be (F5) 3.33±0.03, friability was found to be 0.02±0.070 (F5) and weight variation was found to be 99.98±0.08% (F5). All the evaluation parameters were found to be within the satisfactory limits (IP). The percentage drug release for the optimized formulation F5containing 5% of Crospovidone was 99.97% in 30 mins. The sustained release layer containing drug and Ethyl cellulose in the ratio of (1:2) (F5) released 99.68% of drug at the end of 10 hrs. Drug release followed Krosmeyer peppas. The percentage drug release from the bilayer tablets were 100.2% for immediate release layer at 30 mins and 100.05% for sustained release layer at the end of 10 hrs pH 6.8 phosphate buffer which depicts that the bilayered tablets of Atorvastatin and Pioglitazone will be useful in case of metabolic disorder such as Diabetes milites type 2 and Hyperlipidemia. Keywords: Atorvastatin, Pioglitazone, Guggul gum, Bilayer tablet.