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Optimization of formulation variables to produce free flowing granules of bezafibrate by high-shear mixer using Box-Behnken design

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Author(s): Khalid M. El-Say1, 2, *, Tamer A. Refaey3, Ahmed M. Samy1, Alia A. Badawi 4

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 2;
Start page: 501;
Date: 2011;
Original page

Keywords: Bezafibrate | Box-Behnken design | high-shear mixer | wet granulation | flowability.

ABSTRACT
The objective of the present study was to solve the most important problems which affect the tablet manufacture namely the cohesive and adhesive properties of drugs. These particular properties usually lead to poor flowability, de-mixing and stickiness of material to the machinery parts of compression machine causing friction during the compression process, and producing undesirable tablet properties. This could be achieved by improving the flowability and ompressibility of poorly flowable and highly cohesive bezafibrate (BZ) by wet granulation using high-shear mixer prevailing to its compression into tablets. Fifteen formulations, designed by Box-Behnken design (BBD), were produced with different proportions of hydroxypropyl methylcellulose (HPMC), Aerosil, and magnesium stearate.BBD was employed to study the relations among the variables and to statistically optimize the formulation parameters of BZ preparation for maximum % of mean granule size (Y1), minimum angle of repose (Y2), minimum ejection force (Y3), minimum disintegration time (Y4) and maximum drug release(Y5). BBD was suitable for exploring quadratic response surfaces and constructing second order polynomial models. The significance of estimation of the model was determined byStudent’s t-test. The design consists of replicated center points and the set of points lying at the midpoint of each edge of the ultidimensional cube that defines the region of interest. Contour and response surface plots were depicted based on the equation given by the model. A formula was prepared under the optimized conditions yielding response values, which were close to the predicted values. Thus, this study proved that experimental design methodology could efficiently be applied for characterization and optimization of formulation parameters affecting the flowability, compressibility ensuring adequate physical and technical properties needed for the production of smooth and strong BZ tablets.
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