FORMULATION DEVELOPMENT AND OPTIMIZATION OF TELMISARTAN TABLETS EMPLOYING βCD STARCH 1500 AND SOLUPLUS

The objective of the present study is optimization of telmisartan tablet formulation employing βCD, Starch 1500, and Soluplus by 2 3 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. The individual and combined effects of the three factors, βCD, Starch 1500 and Soluplus are highly significant (P < 0.01) in influencing the dissolution rate of Telmisartan tablets.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) , Starch 1500 (X2) and Soluplus (X3) based on the observed results was found to be Y = 55.33 + 3.61(X1) + 35.07(X2) – 9.18(X1 X2) – 3.76(X3) – 3.31(X1 X3) + 2.06(X2 X3) + 1.77(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, Starch 1500 at 27.82% of drug and βCD content , and Soluplus at 1% of drug and βCD content. The optimized telmisartan tablet formulation gave 85.5% dissolution in 10min fulfilling the target dissolution requirement. Formulation of telmisartan tablets with NLT 85% dissolution in 10 min could be optimized by 2 3 factorial design. Key words: Formulation Development, Telmisartan tablets, Optimization, Factorial Design, βCD,Starch 1500,Soluplus