Study the effect of formulation variables in the development of timed-release press-coated tablets by Taguchi design

Abstract

In this investigation, the effect of formulation variables on the release properties of timed- release press-coated tablets was studied using the Taguchi method of experimental design. Formulations were prepared based on Taguchi orthogonal array design with different types of hydrophilic polymers (X1), varying hydrophilic polymer/ethyl cellulose ratio (X2), and addition of magnesium stearate (X3) as independent variables. The design was quantitatively evalu-ated by best fit mathematical model. The results from the statistical analysis revealed that factor X1, X3 and interaction factors between X1X2 and X1X3 were found to be significant on the re-sponse lag time (Y1), where as only factor X1 was found to be significant on the response percent drug release at 8 hrs (Y2). A numerical optimization technique by desirability function was used to optimize the response variables, each having a different target. Based on the re-sults of optimization study, HPC was identified as the most suitable hydrophilic polymer and incorporation of hydrophobic agent magnesium stearate, could significantly improve the lag time of the timed-release press-coated tablet.