FORMULATION AND DEVELOPMENT OF TELMISARTAN TABLETS EMPLOYING FACTORIAL DESIGNS AND STABILITY

The individual main effect and combined effect of commonly used β Cyclodextrin, Binders, disintegrants on the dissolution rate of telmisartan tablets were studied in 23 factorial designs employing selected combinations of 3 factors (β Cyclodextrin, Binders, disintegrants) of eight formulations of telmisartan tablets were prepared and evaluated All the telmisartan tablets were prepared good quality with regard to drug content, hardness, friability and disintegration time to fulfill official (IP) specifications of uncoated tablets. Many variations were observed in all the dissolution parameters of tablets prepared due to formulation variables. The ANOVA of dissolution rate (K1) indicates the individual main effect and combined effect of β Cyclodextrin, Binders, disintegrants on the dissolution rate constant (K1) are significant (P < 0.05). The ANOVA of dissolution efficiency (DE30) indicates that individual main effect and combined effect of β Cyclodextrin, Binders, disintegrants on the dissolution efficiency (DE30) are significant (P < 0.05). Telmisartan tablets formulations Fabc formulated employing 1:2 ratio of β Cyclodextrin (Factor A) and Gelatin (2%) as a Binder (Factor B) and Primogel(5%) as Disintegrant (Factor C) gave highest dissolution rate of Telmisartan 97.5% in 60 min. The increasing order of dissolution rate observed with various formulations was Fabc > Fbc > Fc > Fac > Fab > Fb > Fa > F1. The optimize telmisartan tablets (Fabc) formulated employing1:2 ratio of β Cyclodextrin, Gelatin (2%) and Primogel(5%) are compare to the marketed product (mytel 80). The Differential factor (f1) and similarity factor (f2) indicate identical/similar dissolution profile comparable to marketed product (mytel80).The stability studies were conducted as per ICH guidelines. Keywords: Factorial Design, ANOVA, Binder, Disintegrant, Stability, βCD.