Abstract

AbstractLactose and mixture of lactose and microcrystalline cellulose (1:1) were granulated in a fluid-bed equipment using PVP, acacia and gelatin as binders. The effect of these binders, their concentrations, and volume of granulation liquid on granule growth and granule sue distribution was studied. It has been shown that individual binder and binder concentration affect granule growth and growth mechanism. Also, the volume of granulation liquid and part dissolution of excipients being granulated contribute significantly to the granule size and size distribution. On the basis of granule growth data, a mathematical relationship which relates granule size as a function of binder concentration is proposed. Granule growth constant for the binders is computed from the granule size against binder concentration data. The constant describes granule growth pattern, and is termed as binder coefficient, β. The numerical value of binder coefficient, which varies with the binder, indicates relative activity and effe...

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