Transfer and scale-up of the manufacturing of orodispersible mini-tablets from a compaction simulator to an industrial rotary tablet press
International Journal of Pharmaceutics(2021)
Abstract
•Transfer of ready-to-use excipients from compaction simulator to rotary tablet press is feasible.•Scale-up process of orodispersible mini-tablets following FDA/EMA guidelines succeeds.•Critically quality attributes like mass, tensile strengths and disintegration time are affected during scale-up.
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Key words
Scale-up,Mini-tablets,Functionalized excipients,Direct compression,Rotary tablet press,Compaction simulator
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