2025 Fall
International Convention of PSK

D+7
October 22-24, 2025

Abstracts

P11-12

Comparative study of batch-to-continuous manufacturing process conversion for amiodarone hydrochloride tablets

  • Ju-Hyun Yoon1, Chae-Won Jeon1, Joo-Eun Kim*1,2
  • 1Department of Biopharmaceutical Chemistry, Kookmin University, Seoul, Republic of Korea. 02707
  • 2Biopharmaceutical Chemistry Major, School of Applied Chemistry, Kookmin University, Seoul 02707, Korea

This study aimed to effectively design and optimize the manufacturing process for amiodarone hydrochloride tablets by applying continuous wet granulation. The properties of the resulting granules and tablets were evaluated to compare the differences between a conventional batch process using a high-shear mixer (HSM) and a continuous process using a twin-screw granulator (TSG). Furthermore, twin-screw rpm was identified as a Critical Process Parameter (CPP) affecting granule and tablet properties. A Design of Experiments (DoE), specifically a central composite design, was conducted to establish optimal process conditions. The independent variables (X) investigated were twin-screw rpm and milling size, while the dependent variables (Y) included dissolution, flowability, assay, disintegration, and friability. The results from the comparative study indicated no significant differences in the in-process controls (IPCs) for tablets manufactured by either process. Moreover, the dissolution profiles demonstrated equivalence to the reference drug, with a similarity factor (f2) greater than 50. In conclusion, this study confirms the feasibility of converting the manufacturing of a drug product from a traditional batch-based process to a continuous one


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