Development and Characterization of Miglitol As Immediate Release and Metformin HCL As Sustained Release Bilayered Tablets

ABSTRACT

The purpose of this research work was to formulate an anti-diabetic in a single dosage form i.e. Metformin HCl in sustained release layer and Miglitol in immediate release layer of the bilayer tablet. The tablets were prepared using Hydroxypropyl methylcellulose (HPMC K4M & HPMC K15M, sodium alginate and xantham gum) an as release retarding polymers in various combination and concentrations. The effect of different super disintegrants on immediate release in various concentrations was also studied. Eight formulations of immediate release layer were prepared using SSG and CCS super disintegrants with different proportions and were evaluated for different parameters. Among the eight formulations M4 containing CCS as disintegrant showed a better release of 95.50±0.15% for 30 mins was selected. Using this MT4 formulation eight formulations of sustained release layer of Metformin. HCL was prepared with HPMC k15M polymer and evaluated. Among nine formulations of bilayered tablets MM4 was showed 98.66±0.65% at the end of 8 hrs. was selected as optimized formulation.  This optimized formulation was evaluated for parameters like, thickness, hardness, friability, weight variation, drug content, in vitro   drug release and stability and results were found to be with in  USP limits.

Keywords: Bilayer Tablets, SSG, Croscarmellose sodium, Hydroxypropyl methylcellulose, Metformin, Miglitol, in vitro drug release studies.