Journal: Journal of Pharmacy Research

Article Id: JPRS-PCS-0000186
Title: Optimization of Irbesartan tablet formulation by 22 factorial design
Category: Pharmaceutics
Section: Research Article
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    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 Primojel 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 Primojel and βCD by 22 factorial design. Formulation of irbesartan tablets with NLT 85% dissolution in 15 min employing Primojel and βCD 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. The dissolution rate (K1) values were analysed as per ANOVA of 22factorial design to find the significance of the individual and combined effects of the two factors (βCD and Primojel) involved on the dissolution rate of irbesartan tablets formulated. The individual and combined effects of βCD and Primojel on the dissolution rate (K1) of irbesartan tablets are highly significant (P<0.01). Irbesartan tablets formulated employing Primojel 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,99.51% in 15 min. Higher levels of βCD and lower levels of Primojel gave low dissolution rates of irbesartan tablets.The increasing order of dissolution rate (K1) observed with various formulations was F a> Fab> Fb> F1.The polynomial equation describing the relationship between the response i.e. percent drug dissolved in 15min (Y) and the levels of Primojel (X1) and âCD (X2) based on the observed results is Y = 77.58+16.72 (X1) + 4.44 (X2) - 9.65 (X1 X2) .Based on the above polynomial equation, the optimized irbesartan tablet formulation with NLT 85% dissolution in 15 min could be formulated employing Primojel at 22.56% of drug content and βCD at 1:1.25 ratio of drug: βCD.The optimized irbesartan tablet formulation gave 86.35% dissolution in 15 min fulfilling the target dissolution set. Hence formulation of irbesartan tablets with NLT 85% dissolution in 15 min could be optimized by 22 factorial design.

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    Author(s) Name:

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

    Affiliation(s) Name:

    Vikas Institute of Pharmaceutical Sciences, Nidigatla Road, Rajahmundry- 533103,India. 

    *Corresponding author.
    Prof. K. P. R. Chowdary
    Vikas Institute of Pharmaceutical Sciences,
    Nidigatla Road, Rajahmundry- 533103,India.


    Received on:02-03-2014; Revised on: 08-04-2014; Accepted on:19-04-2014

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    Author:

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

    Title:Optimization of Irbesartan tablet formulation by 22 factorial design
    Journal:Journal of Pharmacy Research
    Vol(issue):8 (April)
    Year:2014
    Page No: (606-609)
  • Experimental Methods Keywords

    Methodology:UV Spectrophotometric method,Disintegration time,Dissolution Rate Study
    Research Materials: Irbesartan tablet

Keywords

Irbesartan tablets Optimization Factorial Design β Cyclodextrin Primojel

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