Diabetes mellitus, being one of the most prevalent disease in India, generally accompanied with major complications like heart attack, cardiomyopathy, stroke and peripheral vascular disease. These conditions account for most morbidity and mortality among middle-aged and older people. Cardiovascular disease is the leading cause of death in individuals with type 2 diabetes. The low compliance and high cost are the major hindrance blocks for multiple drug therapy. The main objective of this research work was to develop optimized bilayer tablets of metformin HCl and amlodipine besilate as twice a day formulation to overcome the problems associated with multiple drug therapy. The drug choice for type-2 diabetes mellitus was metformin HCl and for prevention of diabetes associated CVS complications was amlodipine besilate. The formulations of tablets were prepared by using three matrix forming polymers such as HPMC K15M and HPMC K100M for SR tablets and two super disintegrating agents such as crospovidone and croscarmellose sodium. Various formulation batches were prepared by applying 32 factorial designs for both SR layer and IR layer. Bilayer tablets were prepared from optimized SR and IR layer and then extensively evaluated for in-vitro release behavior for 12 hr. The current investigation concluded that metformin HCl and amlodipine besilate can be incorporated in bilayer tablets, which may successfully improve patient compliance by reducing dose.
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