Formulation Development and Evaluation of the Extended release Dosage Form of Anti Diabatic Drug

Abstract

The drug chosen for the present investigation was DCPT 070, is an orally active anti diabetic agent. It is effectively used in the treatment of non-insulin dependent diabetes mellitus (NIDDM) Type II. Unlike sulfonylurea, DCPT070 usually does not produce hypoglycaemia in diabetic and nondiabetic individuals. So, it is more appropriately referred to as antihyperglycemic agent and found to be well-tolerated and safe on chronic use. DCPT 070 is highly soluble drug as well as having short half life i.e. 2-4 hrs. Its bioavailability is 50-60% only. So main aim is to formulate the drug into extended release formulation which can sustained the drug release for 12 hrs in cost effective manner. The dissolution profile of formulated tablets was match with the innovator product. Extended release formulations were formulated by using different polymers like HPMC K100MCR, HPMC K15MCR, Carbopol 71G and combination of polymers taking polymers intragranularly, extra granularly, intragranularly as well as extra granularly and optimized the all three polymer concentration. Tablets were also prepared to check effect of binder on drug release. The best batch was selected from optimized batches. The tablets were evaluated for various parameters like Hardness, Thickness, Friability, Diameter, Cumulative % drug release. Dose dumping studies also were carried out for optimized batch. Calculation of similarity and dissimilarity factor were calculated taking innovator as reference. Finally batch containing HPMC K100MCR 10% intragranularly and 12% extra granularly was selected as best batch as it have optimized tableting parameters and cumulative % drug release. A result shows that there was no effect of binder on drug release. Similarity factor of best batch was greater than 50.Dose dumping studies reveal that there was no dose dumping in optimized batch.