Formulation, evaluation and optimization of miconazole nitrate tablet prepared by foam granulation technique
Keywords:
miconazole nitrate, foam granulation, oral disintegrating tabletAbstract
The aim of our study was to utilize novel foam granulation technique in formulation of miconazole nitrate; a model hydrophobic drug as oral disintegrating tablets "ODT" particularly to enhance its bioavailability. Foam granulation technique has additional advantages over the other traditional granulation technique since; it enhances the granulation process and produce acceptable tablets. Fractional factorial design was used to investigate the effect of formulation and processing variables on the prepared miconazole ODT. The prepared granules were evaluated by measuring their density, flowability, granules size and shape, and granules wetting time. The quality attributes of the prepared tablets; drug content, tablet thickness, uniformity of weight, tablet tensile strength, friability, disintegration, and dissolution were also evaluated. The results indicated that, the prepared granules showed acceptable characteristics and is significantly affected by the disintegrant type, urea concentration, and the lubricant type. The quality attributes of the tablets were not affected by the processing parameters. From the prepared formulas; F20, F19, F12, and F20 displayed 18, 35, 35, and 40 seconds disintegration time respectively and the percent of dissolution after 15 minutes ranged from 94.4-100%. These results ascertained that foam granulation technique fulfill the requirement in preparation of miconazole ODT.
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