Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing

• Ishimoto Hayato

  Formulation Research, Pharmaceutical Science & Technology Core Function Unit, Medicine Development Center, Eisai Co., Ltd.

• Kano Manabu

  Department of Systems Science, Kyoto University

• Sugiyama Hirokazu

  Department of Chemical System Engineering, The University of Tokyo

• Takeuchi Hirofumi

  Advanced Pharmaceutical Process Engineering, Gifu Pharmaceutical University

• Terada Katsuhide

  Faculty of Pharmacy, Takasaki University of Health and Welfare

• Aoyama Atsushi

  Office of New Drug III, Pharmaceuticals and Medical Devices Agency

• Shoda Takuji

  Division of Organic Chemistry, National Institute of Health Sciences

• Demizu Yosuke

  Division of Organic Chemistry, National Institute of Health Sciences

• Shimamura Jinen

  Pharmaceutical Research Dept. Research & Development Headquarters, TAKATA Pharmaceutical Co., Ltd.

• Yokoyama Reiji

  CMC R&D Division, Shionogi Co., Ltd., Formulation R&D Laboratory

• Miyamoto Yuji

  Formulation Research & Pharmaceutical Process Group, CMC R&D Center, Kyowa Kirin Co., Ltd.

• Hasegawa Koji

  Technical Division, POWREX Corporation

• Serizawa Masaru

  BeatSensing Co., Ltd.

• Unosawa Kazuomi

  R&D Laboratotory, FREUND CORPORATION

• Osaki Kazuo

  Spectroscopy, Metrohm Japan Ltd.

• Asai Naochika

  Industrial Machinery Division, DALTON CORPORATION

• Matsuda Yoshihiro

  Pharmaceuticals and Medical Devices Agency

抄録

As a result of the research activities of the Japan Agency for Medical Research 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 transfer, 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.

収録刊行物

• ＣＨＥＭＩＣＡＬ　＆　ＰＨＡＲＭＡＣＥＵＴＩＣＡＬ　ＢＵＬＬＥＴＩＮ

  ＣＨＥＭＩＣＡＬ　＆　ＰＨＡＲＭＡＣＥＵＴＩＣＡＬ　ＢＵＬＬＥＴＩＮ 69 (2), 211-217, 2021-02-01

  公益社団法人 日本薬学会

キーワード

• continuous manufacturing
• control strategy
• state of control
• Quality by Design (QbD)
• solid drug product
• regulatory science

詳細情報

• CRID: 1391694356264233984
• NII論文ID: 130007979432
• NII書誌ID: AA00602100
• DOI: 10.1248/cpb.c20-00824
• ISSN: 13475223
• ISSN: 00092363
• NDL書誌ID: 031242277
• PubMed: 33298636
• Web Site: http://id.ndl.go.jp/bib/031242277
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I031242277
• Web Site: https://www.jstage.jst.go.jp/article/cpb/69/2/69_c20-00824/_pdf
• 本文言語コード: en
• データソース種別:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• 抄録ライセンスフラグ: 使用不可