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Abstract

OPTIMIZATION OF IRBESARTAN TABLET FORMULATION EMPLOYING ?CD AND CROSPOVIDONE BY 22 FACTORIAL DESIGNS

K. P. R. Chowdary*, K. Ravi Shankar and V. V. L. S. P. Sowjanya

ABSTRACT

Irbesartan, a widely prescribed anti hypertensive drug belongs to class II under BCS classification and exhibit low and variable oral bioavailability due to its poor aqueous solubility. It needs enhancement in the dissolution rate in its formulation development. Complexation with β-cyclodextrin (βCD) and use of Crospovidone are tried for enhancing the dissolution rate of irbesartan in its formulation development. The objective of the present study is optimization of irbesartan tablet formulation employing Crospovidone and βCD by 22 factorial design. Formulation of irbesartan tablets (i) with NLT 85% dissolution in 15 min and (ii) with NLT 70% dissolution in 15 min employing Crospovidone and βCD in each case was optimized by 22 factorial design. Four irbesartan tablet formulations were prepared using selected combinations of the two factors as per 22 factorial design. Irbesartan tablets were prepared by direct compression method and were evaluated for drug content, hardness, friability, disintegration time and dissolution rate characteristics. Irbesartan tablets formulated employing Crospovidone at a level of 30% of drug content and βCD in 1:1 ratio of drug: βCD (Fa) disintegrated rapidly within 20 seconds and gave very rapid dissolution of irbesartan, 97.18% in 15 min. Higher levels of βCD and lower levels of Crospovidone gave low dissolution rates of irbesartan tablets. The increasing order of dissolution rate (K1) observed with various formulations was F a> Fab> F1> Fb.The polynomial equation describing the relationship between the response i.e. percent drug dissolved in 15min (Y) and the levels of rospovidone (X1) and βCD (X2) based on the observed results is Y=60.37+33.04 (X1) – 5.03 (X2) + 1.265 (X1 X2). Based on the above polynomial equation, two optimized Irbesartan tablet formulations, One with high dissolution (OPT1) with NLT 85% dissolution in 15 min could be formulated employing Crospovidone at 24.75% of drug content and βCD at 1:1 ratio of drug:βCD and the other with moderate dissolution (OPT2) with NLT 70% dissolution in 15 min could be formulated employing Crospovidone at 19.07% of drug content and βCD at 1:2 ratio of drug: βCD .The optimized irbesartan tablet formulation,OPT1 gave 88.27% dissolution in 15 min and formulation OPT2 gave 73.48% dissolution in 15 min fulfilling the target dissolution set in each case.The results indicated validity of the optimization technique employed and the polynomial equation developed could be used to formulate Irbesartan tablets with any desired dissolution rate specification. Hence formulation of irbesartan tablets with any desired dissolution rate specification could be optimized by 22 factorial design.

Keywords: Irbesartan tablets, Optimization, Factorial Design, ? Cyclodextrin, Crospovidone.


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