Approach to establishment of control strategy for oral solid dosage forms using continuous manufacturing

Ishimoto, Hayato; Kano, Manabu; Sugiyama, Hirokazu; Takeuchi, Hirofumi; Terada, Katsuhide; Aoyama, Atsushi; Shoda, Takuji; Demizu, Yosuke; Shimamura, Jinen; Yokoyama, Reiji; Miyamoto, Yuji; Hasegawa, Koji; Serizawa, Masaru; Unosawa, Kazuomi; Osaki, Kazuo; Asai, Naochika; Matsuda, Yoshihiro

Approach to establishment of control strategy for oral solid dosage forms using continuous manufacturing

By Ishimoto, Hayato; Kano, Manabu; Sugiyama, Hirokazu; Takeuchi, Hirofumi; Terada, Katsuhide; Aoyama, Atsushi; Shoda, Takuji; Demizu, Yosuke; Shimamura, Jinen; Yokoyama, Reiji; Miyamoto, Yuji; Hasegawa, Koji; Serizawa, Masaru; Unosawa, Kazuomi; Osaki, Kazuo; Asai, Naochika; Matsuda, Yoshihiro

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Published on CMKC

09 Jun 2023

Abstract

As a result of the Research Article activities of the Japan Agency for Medical Research Article and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology trans fer, process control, and quality control used in the current commercial batch manufacturing would be effective also in continuous manufacturing, while there are differences in the process development using continuous manufacturing and batch manufacturing. This document introduces an example of the way of thinking for establishing a control strategy for continuous manufacturing processes.

Journal

Chemical and Pharmaceutical Bulletin. Volume 69, 2021, 211-217

DOI

10.1248/cpb.c20-00824

Type of publication

Peer-reviewed journal

Affiliations

Eisai Inc
Kyoto University
The University of Tokyo

Article Classification

review article

Classification Areas

PAT
Oral solid dose
Control