Chemical and Pharmaceutical Bulletin
Online ISSN : 1347-5223
Print ISSN : 0009-2363
ISSN-L : 0009-2363
Regular Articles
Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing
Hayato IshimotoManabu KanoHirokazu SugiyamaHirofumi TakeuchiKatsuhide TeradaAtsushi AoyamaTakuji ShodaYosuke DemizuJinen ShimamuraReiji YokoyamaYuji MiyamotoKoji HasegawaMasaru SerizawaKazuomi UnosawaKazuo OsakiNaochika AsaiYoshihiro Matsuda
Author information
JOURNALS FREE ACCESS FULL-TEXT HTML

2021 Volume 69 Issue 2 Pages 211-217

Details
Abstract

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.

Graphical Abstract Fullsize Image
Information related to the author
© 2021 The Pharmaceutical Society of Japan
Previous article Next article
feedback
Top