4.7 Article

The effect of binder types on the breakage and drying behavior of granules in a semi-continuous fluid bed dryer after twin screw wet granulation

Journal

INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 614, Issue -, Pages -

Publisher

ELSEVIER
DOI: 10.1016/j.ijpharm.2022.121449

Keywords

Twin screw wet granulation; Continuous manufacturing; Formulation development; Fluid bed dryer; Binder types; Granule breakage; Granule drying

Funding

  1. Roquette Freres
  2. INTERREG V 2 Mers Seas Zeeen Crossborder Cooperation Programme 2014 -2020 [2S01-059]

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This study investigated the impact of different binder types on the drying process and breakage behavior of granules. It was found that the binder type did not affect granule breakage during drying, but differences were observed during pneumatic transport. Additionally, the liquid requirements played a crucial role in the drying process and were dependent on the chosen binder.
Current study investigated the effect of different binder types on the granule drying process and the granule breakage behavior in a semi-continuous fluid bed dryer integrated in the C25 ConsiGma-system. The studied binders (i.e. hydroxypropyl pea starch, hydroxypropyl methylcellulose E15, polyvinylpyrrolidone K12, and starch octenyl succinate CO 01) required different liquid amounts to produce similar granule quality. These different liquid requirements were translated into different drying conditions for each binder to result in suffi-ciently dry granules at the end of a drying cycle. By comparing the size distribution of the granules before entering and after exiting the fluid bed dryer, granule breakage could be evaluated. No effect of the binder type on the granule breakage during drying was observed. However, differences in granule breakage were observed for the binders when processed with the horizontal set-up of the C25 system, as granule breakage during pneumatic transport depended on the binder type. Only one binder (hydroxypropyl pea starch) allowed to avoid granule breakage during the entire process. Furthermore, this research showed that the drying process was mainly steered by the liquid requirements for granulation, and that these liquid requirements depended on the binder used.

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