FORMULATION, OPTIMIZATION AND EVALUATION OF FLOATING TABLETS CLARITHROMYCIN
Keywords:
Floating tablets, Gastric retention, Clarithromycin, Factorial designAbstract
Objective: The present aim of this study was to formulate, optimize and evaluation of floating tablets of Clarithromycin.
Methods: Floating tablets of Clarithromycin were formulated using polymer HPMC K15M with sodium bicarbonate as gas generating agent by wet granulation method. A 32 factorial design were applied to systematically optimize the drug release profile. The amount of citric acid (X1) and concentration of polymer HPMC K15M (X2) was selected as independent variables. The drug release at 6 hours (Q6) and drug release at 12 hour (Q12), and diffusion exponent (n) was selected as dependent variables.
Results: The results of factorial design indicated that low level of HPMC K15M favors the preparation of floating controlled release of Clarithromycin tablets. The tablets were evaluated for thickness, hardness, weight variation, floating lag time, total floating time, swelling index, drug content uniformity and in vitro drug release in 0.1N HCL (pH 1.2). The in vitro dissolution profiles of all the prepared Clarithromycin floating drug delivery system formulations was found to extend the drug release over a period of 10 to 12 hours and the drug release rate decreased with increase in polymer concentration.
Conclusion: It can be concluded that the decreased in citric acid concentration in the formulation showed decreased in drug release, this is due to citric acid reaction with sodium bicarbonate resulting generation of carbon dioxide gas at a faster rate, increased rate of drug release. Increasing the concentration of HPMC K15M resulted in reduction of drug release.
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