APPLICATION OF RESPONSE SURFACE METHODOLOGY TO OPTIMIZE THE TECHNOLOGY OF METFORMIN ORAL DISSOLVING TABLETS

Abstract

To improve the compliance of patients with type 2 diabetes there is a need to develop metformin oral dissolving tablets, which disintegrate and dissolve rapidly in the saliva. The aim of this study was to optimize the composition of metformin orodispersible tablets. The central composite design was used to establish the relation between independent variables, such as, quantity of MCC Burst, quantity of Neusillin US2, and dependent variables, such as, flowability, bulk density, tapped density, uniformity of weight, friability, tablet hardness, disintegration time, wetting time in order to obtain the optimal formulation using Response Surface Methodology. After generating the polynomial equations that relate the dependent and independent variables, the process was optimized for five responses. From the dissolution studies, it is confirmed that all formulations released more than 82% of the metformin within 3 min. It was found that the tablet containing 3% MCC Burst and 5% Neusillin US2 was a better formulation in terms of hardness (72 N), uniformity of weight (1.09%), friability (0.75%), rapid disintegration (33 sec) and drug release (95.0%) when compared with all other formulations.