Formulation and evaluation of a co-disintegrant mixture in metronidazole tablet using Quality by design approach
The aim of this study was to assess the disintegrant property of Sammaz Maize starch (MS) and Khaya senegalensis gum (KG) and the potential effects of mixing the disintegrants to select an optimized concentration for the formulation of immediate release tablets of metronidazole manufactured via direct compression. Design of Experiments (DoE) was employed to derive the ratios for the combination and also to optimize the composition using the desirability function. The optimized formulation contained MS (1.86%) and KG (8.14%) as disintegrant. Tablets were prepared by direct compression and tablet quality tests were carried out. The formulations produced non-friable tablets (friability- 0.632-1.07 %) with sufficient hardness of between 3.9-5.4 KgF and displayed rapid disintegration between 7.5 to 11.67 seconds showing a super disintegrant property. The physical combination of MS and KG was found to be an effective co-disintegrant mixture in immediate release tablets of metronidazole and displayed novel super disintegrant characteristics.
Keywords: Khaya senegalensis gum, Optimized, Sammaz maize starch, Superdisintegrant
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