Granulation of core particles suitable for film coating by agitation fluidized bed III. Effect of scale, agitator rotational speed and blade shape on granule properties and development of a high accuracy scale-up theory.
The preparation of core particles suitable for subsequent film coating was examined using different scales of agitation fluidized beds. Specifically, the effects of agitator rotational speed and agitator blade shape in different scales of granulators on granule properties such as mass median diameter, apparent density, friability and shape factor were studied. As the agitator rotational speed was increased or when the agitator blade height and angle were large, the mass median diameter and friability of the granules decreased, while the apparent density and shape factor increased, in a manner independent of the vessel size because the granules were subjected to greater compression, shearing and rolling effects. The same core particles could not be prepared using granulators with different vessel sizes by simply adopting a conventional scale-up theory(1,2)) based on kinetic energy similarity. Here, a novel scale-up theory that takes into account agitator blade shape factors is proposed.(3)) When the two scale-up theories were compared, our new theory was capable of predicting the granule properties more accurately than the conventional theory. By adopting this novel theory, the same core particles could be prepared under different operating conditions in any scale of granulator.
Hamashita
Tomohiro
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Oral Solid Formulation, R&D Laboratories, Self Medication Business, Taisho Pharmaceutical Co., Ltd, Saitama, Japan. tomohiro.hamashita@po.rd.taisho.co.jp
Ono
Tetsuo
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Ono
Masaki
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Tsunenari
Yoshinobu
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Aketo
Takao
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Watano
Satoru
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