Abstract

FORMULATION DEVELOPMENT OF TELMISARTAN TABLETS: OPTIMIZATION BY 23 FACTORIAL DESIGN

Lakshmanarao P., Chowdary K.P.R.* and Prasad S.V.U.M.

ABSTRACT

The objective of the present study is optimization of telmisartan tablet formulation employing βCD, Primojel and Tween 80 by 23 factorial design to achieve NLT 85% dissolution in 10 min. Eight telmisartan tablet formulations were prepared using selected combinations of the three factors as per 23 factorial design. Telmisartan tablets were prepared by direct compression method and were evaluated. Telmisartan tablet formulations Fb and Fbc disintegrated rapidly in 20 and 40 seconds and gave very rapid dissolution of telmisartan, 96.1% and 95.8% in 10 min respectively. The increasing order of dissolution rate (K1) observed with various formulations was Fc< F1< Fac< Fa< Fabc< Fab< Fbc< Fb. The polynomial equation describing the relationship between the response, percent drug dissolved in 10min (Y) and the levels of βCD (X1), Primojel (X2) and Tween 80 (X3) based on the observed results is Y = 55.327 + 3.613(X1) + 35.072(X2) – 9.182(X1 X2) – 3.757(X3) – 3.317(X1 X3) + 2.06(X2 X3) + 1.765(X1 X2 X3). Based on the above equation, the formulation of optimized telmisartan tablets with NLT 85% dissolution in 10 min require βCD at 1:3.5 ratio of drug: βCD, Primojel at 27.84% of drug content, and Tween 80 at 1% of drug content. The optimized telmisartan tablet formulation gave 85.85% dissolution in 10min fulfilling the target dissolution requirement.

Keywords: Formulation Development, Telmisartan tablets, Optimization, Factorial Design.