Abstract :
The objective of the present study is optimization of telmisartan tablet formulation employing HPβCD, 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.
ANOVA of K1 values indicated that the individual and combined effects of HPβCD (Factor A) and Primojel (Factor B) in
influencing the dissolution rate of telmisartan tablets are highly significant (P < 0.01). The effect of Tween 80 (Factor C) and the
combined effects of AC, BC and ABC are not significant (P˃0.05).Telmisartan tablet formulations Fb, Fbc and Fabc disintegrated
rapidly within 1 min and gave very rapid dissolution of telmisartan more than 90% in 10 min . The increasing order of
dissolution rate (K1) observed with various formulations was Fc< F1< Fac< Fa< Fabc< Fab< Fb< Fbc. The polynomial equation
describing the relationship between the response, percent drug dissolved in 10min (Y) and the levels of HPβCD (X1) , Primojel
(X2) and Tween 80 (X3) based on the observed results was found to be Y = 56.097 + 3.663(X1) + 38.036(X2) – 9.146(X1X2) –
3.77(X3) – 3.38(X1X3) + 2.073(X2X3) + 1.767(X1X2X3).Based on the above equation, the formulation of optimized telmisartan
tablets with NLT 85% dissolution in 10 min require HPβCD at 1:3.5 ratio of drug: HPβCD, Primojel at 26.626% of drug and
HPβCD content , and Tween 80 at 1% of drug and HPβCD content. The optimized telmisartan tablet formulation gave 85.55%
dissolution in 10 min fulfilling the target dissolution .
Keyword :
Telmisartan tablets, Optimization, Hydroxy propyl β-cyclodextrin, Primojel, Tween 80, Factorial Design