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3.145.8.2

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

View Resource (DOI)

Category

Peer-reviewed journal

Published on

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

Tags

  1. continuous manufacturing
  2. Control
  3. Control strategy
  4. oral solid dose
  5. pat
  6. Quality by Design (QbD)
  7. Regulatory science
  8. Review article
  9. Solid drug products
  10. State of control