Fluid bed granulation of a poorly water soluble, low density, micronized drug: comparison with high shear granulation

A Comparison of Granules Produced by High-Shear and Fluidized-Bed Granulation Methods

“…At larger granule sizes, this structure becomes particularly susceptible to attrition as shown by the decrease in agglomerates and increase in fines near the end of the granulation. The differences in the granule shape and porosity were consistent with the reported literature (4)(5)(6)9).…”

“…The range in the Carr index for the fluidized-bed granulation trials reflects the differences in the size distributions with larger granules, which would exhibit better flow properties, obtained for the trials at the lower fluidization velocity. Gao et al (6) reported similar Carr index values: 13 for granules from high-shear granulation and 15 to 26 for granules from fluidized-bed granulation with the different process parameters affecting the values.…”

“…Variations in reported granule properties may be attributed to formulations or differences in granulation equipment and process parameters. The effect of the granulation method on granule flowability has only been reported by Gao et al (6) using the Carr index. A thorough study on the effect on flowability, specifically using dynamic measurements, has not yet been reported.…”

“…Gao et al (6) conducted fluidized-bed granulations in a Niro MP-1, varying inlet temperature, inlet air flow, binder spray rate, and atomizing air pressure. High-shear granulations were completed in a Gral 10 L unit, using an experimentally optimized process with drying in a Glatt WSG-3 fluid bed dryer.…”

Study of fluid bed granulation processes with new technology approaches

“…Both the spraying and drying of the agglomerates are carried out in a single piece of equipment offering several advantages over other multi-step granulation and drying processes (Smith, 1980;Kivikero et al, 2007;Närvänen, 2008;Petrović et al, 2011). This results in the reduction of the manufacturing processes and manufacturing time, which benefits the Good Manufacturing Practice (GMP) requirements (Gao et al, 2002). Nowadays, the fluidized bed is applied for drying, agglomeration, and pellets coating (Nikowitz et al, 2013).…”