Development and Evaluation of Two Layered Tablet of Glimepiride and Metformin Hydrochloride for the Treatment of Hyperglycemia

The aim of the present work was to develop a robust formulation of Bi-layer tablets of Glimepiride and Metformin Hydrochloride using polymers such as HPMC K100M (Hydroxy propyl methyl cellulose) and Povidone K25 as binder to modulate the drug release. The basic aim of any Bi-layer tablet formulation is to separate physically or chemically incompatible ingredients and to produce repeat action or prolonged action tablet. Though there are numerous drugs for treating type II diabetes, sulphonyl ureas and biguanides are used commonly by a wide section of patients. Glimepiride act by stimulating the release of insulin from functioning pancreatic beta cells. Metformin hydrochloride helps to suppress appetite and diminishes hepatic glucose excretion, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. It doesn’t stimulate insulin release and the combination of these two drugs is more effective than single drug therapy to treat NIDDM (Non insulin dependent Diabetes mellitus). A total number of seven formulations have been taken to optimize and develop a robust and stable formulation. Wet granulation process was used for the formulation of both layers and the tablets were evaluated for the weight variation, thickness, hardness, friability, dissolution study. The in-vitro release profile shows the desired biphasic behavior. The Glimepiride was dissolved within 45 min, where as Metformin hydrochloride was able to release more than 12 hrs. Among the formulations tablets of formulation FG7-FM7 was taken as optimized formula due to its higher rate of dissolution and compiled all other parameters with the official specifications.