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Abstract

FORMULATION AND EVALUATION OF LOSARTAN POTASSIUM FLOATING TABLETS: OPTIMIZATION BY 23 FACTORIAL DESIGN

K. P. R. Chowdary*, K. Ravi Shankar and T.Vijay

ABSTRACT

The objective of the present study is optimization of Losartan Potassium floating tablet formulation by 23 factorial design. Floating tablets of losartan potassium (50 mg) were formulated employing HPMC K15M (50 %) as matrix forming polymer, sodium bicarbonate as gas generating agent and beeswax and ethyl cellulose as floating enhancers. Losartan Potassium floating tablets were formulated as per 23 factorial design. The three factors involved in the 23 factorial design are sodium bicarbonate (Factor A), beeswax (Factor B) and ethyl cellulose (Factor C). The two levels of sodium bicarbonate (Factor A) are 10 and 20 %, the two levels of beeswax (Factor B) are 2 % and 5 % and the two levels of ethyl cellulose (Factor C) are 5% and 10%. Eight losartan potassium floating tablet formulations were prepared employing selected combinations of the levels of the three factors as per 23 factorial design. All the floating tablets prepared were evaluated for drug content, hardness, friability, disintegration time, floating lag time, floating time and drug release characteristics. Losartan Potassium floating tablets prepared as per 23 factorial design were non-disintegrating in water and aqueous acidic (pH 1.2) and alkaline (pH 7.4) fluids and were of good quality with regard to drug content, hardness, friability and suitable for controlled release. ANOVA indicated that the individual effects of sodium bicarbonate (Factor A), bees wax (Factor B) and ethyl cellulose (Factor C) and the combined effects of sodium bicarbonate and bees wax (AB), sodium bicarbonate and ethyl cellulose (Factor AC) on the floating lag time are highly significant (P < 0.01).Formulations Fabc, Fac, Fab and Fa exhibited excellent floating over 24 h with a floating lag time in the range 9-48 seconds. Higher levels (20 %) of sodium bicarbonate gave shorter floating lag time. Losartan potassium release from the floating tablets prepared except formulation Fa was slow and spread over 12 h and dependent on the composition of the tablets. Drug release from formulation Fa was very rapid. Losartan Potassium release from the floating tablets was by non-fickian diffusion mechanism. Optimization of losartan potassium floating tablet formulation was done taking floating lag time as the parameter for optimization. For optimization, floating lag time was taken as response (Y) and level of sodium bicarbonate as (X1), level of bees wax as (X2) and level of ethyl cellulose as (X3). The polynomial equation describing the relationship between the response, Y and the variables, X1 , X 2 and X3 based on the observed data was found to be Y = 12.96 - 13.09 (X1) + 7.70 (X2) – 7.86 (X1 X2) -2.92 (X3) - 3.08(X1 X3) + 0.32 (X2 X3) - 0.18(X1 X2 X3). Based on the polynomial equation developed, the optimized losartan potassium floating tablet formulation with a floating lag time of 20 seconds or 0.33 min could be formulated employing sodium bicarbonate (100mg/tablet), beeswax (17.5mg/tablet) and ethyl cellulose (37.5mg/tablet). The optimized formulation (Fopt) exhibited a floating time of 24 h with a lag time of 16-20 seconds fulfilling the target floating lag time set indicating validity of the optimization technique employed. Formulations Fopt, Fab, Fac and Fabc prepared exhibited excellent floating characteristics (floating over 24h with a lag time in the range 09 to 48 seconds) and good sustained release of losartan potassium over 12 h. As such, these formulations are considered as the best floating tablet formulations of losartan potassium suitable for b.i.d administration.

Keywords: Floating tablets, Losartan potassium, Optimization, Factorial design, Sustained release.


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