Investigation of the effect of impeller speed on granules formed using a PMA-1 high shear granulator

摘要: Impeller speed was varied from 300 to 1500 rpm during the wet high shear granulation of a placebo formulation using new vertical shaft PharmaMATRIX-1 granulator. The resulting granules were extensively analysed for differences caused by varying impeller with emphasis on flowability. Microscopy showed that initial formed primarily microcrystalline cellulose at all tested speeds. At low in "bumpy" flow regime, forces insufficient incorporate components into and promote granule growth size significantly improved "roping" regime higher speeds promoted median particle least 100 µm flowability mixture. Particle distribution measurements advanced indicators based avalanching behavior, however, an 700 produced largest fraction optimal best potential. This allowed good development sufficient mixing, collision rates kinetic energy collisions while minimizing excessive centrifugal buildup around bowl perimeter.