Using experimental design to optimize the process parameters in fluidized bed granulation.
In this study many parameters were screened for a small-scale granulation process for their effect on the yield of granules between 75 and 500 microns and the geometrical granule mean size (d50). First a Plackett-Burman design was applied to screen the inlet air temperature, the inlet flow rate, the spray rate, the nozzle air pressure, the nozzle spray diameter, and the nozzle position. The Plackett-Burman design showed that the key process parameters were the inlet flow rate and the spray rate and probably also the inlet air temperature. Afterward a fractional factorial design (2(5-2)) was applied to screen the remaining parameters plus the nozzle aircap position and the spraying time interval. The fractional factorial design showed that the nozzle air pressure was also important. As the target values for the granule yield (between 75 and 500 microns) and the geometric mean granule size (between 300 and 500 microns) were reached during the screening experiments, further optimization was not considered necessary.
Farmaceutisch Instituut, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090 Brussels, Belgium. brambali@janbe.jnj.com
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Rambali
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Baert
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Thoné
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Massart
D000392:Air Movements; D004867:Equipment Design; D008962:Models, Theoretical; D012107:Research Design; D013607:Tablets; D013678:Technology, Pharmaceutical
D013607:Tablets