Application of manufacturing Classification System to manufacturing method selection for oral solid dosage forms in Japan

The Manufacturing Classification System (MCS) classifies oral solid dosage forms according to the properties of the active pharmaceutical ingredient (API) to improve the selection of appropriate manufacturing methods. The concept of MCS was proposed by a group of European and American pharmaceutical scientists as part of the MCS Working Group. This topic has also generated interest in Japan, and the Japan Pharmaceutical Manufacturers Association (JPMA) considers it useful to investigate the actual status of manufacturing method selection in Japan with application of MCS framework. Since the manufacturing method and its selection are not in the public domain in Japan, the JPMA MCS project team conducted a survey in collaboration with the member companies. This paper summarizes the results of this survey and provides a proposal for the industrial environment in Japan while taking into account the results of the previous EU/US surveys. (c) 2024 The Society of Powder Technology Japan. Published by Elsevier B.V. and The Society of Powder Technology Japan. All rights are reserved, including those for text and data mining, AI training, and similar technologies.