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• W2183620705 abstract "INTRODUCTION Optimization of pharmaceutical formulations involves choosing and combining ingredients that will result in a formulation whose attributes confirm with certain prerequisite requirements. The choice of the nature and qualities of additives (excipients) to be used in a new formulation shall be on a rational basis. The application of formulation optimization techniques is relatively new to the practice of pharmacy. In general the procedure consists of preparing a series of formulations, varying the concentrations of the formulation ingredients in some systematic manner. These formulations are then evaluated according to one or more attributes, such as hardness, dissolution, appearance, stability, taste and so on. Based on the results of these tests, a particular formulation (or series of formulations) may be predicted to be optimal. The optimization procedure is facilitated by applying factorial designs and by the fitting of an empirical polynomial equation to the experimental results. The predicted optimal formulation has to be prepared and evaluated to confirm its quality. 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. Because of poor aqueous solubility and dissolution rate it poses challenging problems in its tablet formulation development. It needs enhancement in the dissolution rate in its formulation development. Several techniques such as micronisation, cyclodextrin-complexation, use of surfactants, solubilizers and super disintegrants, solid dispersion in water soluble and water dispersible carriers, microemulsions and self emulsifying micro and nano disperse systems have been used to enhance the solubility, dissolution rate and bioavailability of poorly soluble BCS class II drugs. Among the various 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 βcyclodextrin (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 βCD and Crospovidone by 2 factorial design. Formulation of irbesartan tablets with NLT 85% dissolution in 10 min employing βCD and Crospovidone was optimized by 2 factorial design. Four irbesartan tablet formulations were prepared using selected combinations of the two factors as per 2 factorial design. Irbesartan tablets were prepared by direct compression method and were evaluated for drug content, hardness, friability, disintegration time and dissolution rate characteristics. The dissolution rate (K1) values were analysed as per ANOVA of 2 2 factorial design to find the significance of the individual and combined effects of the two factors (βCD and Crospovidone) involved on the dissolution rate of irbesartan tablets formulated. The individual and combined effects of βCD (Factor A) and Crospovidone (Factor B) on the dissolution rate (K1) of irbesartan tablets are highly significant (P Fab > F1 > Fa. The polynomial equation describing the relationship between the response i.e. percent drug dissolved in 10min (Y) and the levels of βCD (X1) and Crospovidone (X2) based on the observed results is Y = 55.833 – 5.557(X1) +31.492(X2) +0.682(X1 X2). Based on the above polynomial equation, Irbesartan tablet formulation with NLT 85% dissolution in 10 min could be formulated employing βCD at 1:3 ratio of drug: βCD (300 mg per tablet) and Crospovidone at 28.96 % of drug content (28.96 mg per tablet). The optimized Irbesartan tablet formulation, Fopt gave 85.45% dissolution in 10min fulfilling the target dissolution set. The results indicated validity of the optimization technique employed and the polynomial equation developed could be used to formulate irbesartan tablets with the desired dissolution rate specification. Hence formulation of irbesartan tablets with the desired dissolution rate specification (85% dissolution in 10 min) could be optimized by 2 factorial design." @default.
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• W2183620705 date "2014-01-01" @default.
• W2183620705 modified "2023-09-27" @default.
• W2183620705 title "FORMULATION DEVELOPMENT OF IRBESARTAN TABLETS: OPTIMIZATION BY 2 2 FACTORIAL DESIGN" @default.
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