Statistical Designing and Characterization of Valsartan Oral Disintegrating Tablet

Abstract

The present study involves the formulation and characterization of valsartan (VT) oral disintegrating tablets by using crospovidone (CP) and Hibiscus rosasinensis (HRS) mucilage as complexing agent. Valsartan (VT), anti-hypertensive drug (class II) is an orally active non-peptide triazole-derived antagonist of angiotensin II. The direct compression method was used to obtain 13 such formulations, and the tablets obtained were evaluated for drug content, hardness, friability (FT), disintegration time (DT) and dissolution rate. A significant increase in the dissolution rate of VT was obtained. FTIR and DSC studies showed no interaction between the drug and excipients. The amount of CP (X1) and amount to HRS mucilage (X2) is selected for 32 factorial designs. The DT (Y1), FT (Y2) and % drug released at 25 min (Y3) interval were taken as the response variables. X1 and X2 represents the result of changing the variable at a time from low level to high level. The interaction terms (X1X2, X12, X22, X12X2 and X1X22) exhibited that Y1, Y2 and Y3 had changed simultaneously (as analyzed by Design expert software 8 version). The contour and 3D plots revealed that there is an effect of X1 and X2 with the interaction on Y1, Y2 and Y3. F2 formulation exhibited minimum errors with CP and HRS in response to dependable variables which is concluded as best formulation.