Design and Characterization of Sustained Release Tablet Formulation Containing Metformin Hydrochloride and Simvastatin.

The aim of the present work was to develop pharmaceutical combinational dosage form for simultaneous treatment of patients with type 2 diabetes with at high-risk of coronary disease associated comorbidities. Metformin, an antidiabetic drug is used to treat the diabetic patient and combined with Simvastatin which is HMG-CoA reductase inihibitor drug to treat the high-risk coronary disease simultaneously. In this formulation, three batches were prepared by the direct compression method. Preformulation parameters such as identification, solubility, melting point, compatibility studies, Precompression parameters such as bulk density, tapped density, angle of repose, Hausner ratio, compressibility index, and Post-compression parameters like weight uniformity, hardness, drug content, thickness, in-vitro drug release. In-vitro drug release of all formulations, B1, B2, and B3 was carried out in 0.1N HCl for 2hrs and 10 hrs in phosphate buffer (pH 6.8) dissolution media. Among all the formulations, B3 was an optimized batch. B3 formulations showed drug release of 85% for Metformin Hydrochloride and 93% for Simvastatin over a period of 12hrs. [ABSTRACT FROM AUTHOR]