DESIGN AND EVALUATION OF FOOD GRADE WAX MATRIX SUSTAINED RELEASE MINI-TABLETS OF MONTELUKAST SODIUM
Objective: The objective of this study is to formulate a tablet that fits in the size range of mini-tablets using wax matrix forming substances, allowsvariation of drug dose and study of drug release kinetics of the dosage form.
Methods: The blends of drug with glyceryl monostearate, purified rice bran wax and carnauba wax that renders the waxes food grade, were preparedand evaluated for precompression characteristics. The blends were compressed into mini-tablets having desirable physical characteristics andwere subjected to tests such as weight variation and friability. The tablets were subjected to drug dissolution test and the release parameters weremathematically treated for order and mechanism of drug release.
Results: The tablets complied with the pharmacopoeial standards of physical characteristics. The release was satisfactorily sustained (up to 10 hrs)by carnauba wax and rice bran wax, but not by glyceryl monostearate (only up to 4 hrs). The release followed a zero order with super Case II transportbeing the major mechanism of drug release.Conclusion: Wax matrix formers were satisfactorily used for sustained drug release mini-tablets. The tablets had good physical characteristics withmajor mechanism of drug release being super Case II transport.
Keywords: Wax matrix, Sustained release, Mini-tablets, Montelukast sodium.
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