Design of polypill for treatment of type -II diabetes mellitus associated with dyslipidemia

Abstract

This study presents development of a bilayered tablet with sustained release (SR) of Metformin hydrochloride (MH) and immediate release of Atorvastatin calcium (AC), used as anti-hyperglycemic agent in patients with type 2 diabetes, by lowering

both basal and postprandial plasma glucose and competitive inhibitor of HMG-CoA reductase. In SR layer, sodium carboxy methyl cellulose (Sodium CMC) and Hydroxy Propyl Methylcellulose K4M (HPMC K4M) were used as retarding material but

Hydroxy Propyl Methylcellulose 15 Cps (HPMC 15 Cps) was used as channeling agent. Tablets were prepared by wet granulation method. FT-IR studies showed no interaction between drugs and polymers used in the study. Optimized formulation

gave an initial burst effect and followed by SR for 8 h (92.53%), without any drug degradation during stability studies. Drug release from formulation was dose dependent and by diffusion mechanism.