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Control strategy and methods for continuous direct compression processes

Asian Journal of Pharmaceutical Sciences 2021年第2期16卷 253-262页

作者： Yasuhiro Suzuki Hirokazu Sugiyama Manabu Kano Ryutaro Shimono Gosuke Shimada Ryoichi Furukawa Eichi Mano Keiichi Motoyama Tatsuo Koide Yasuhiro Matsui Kazuki Kurasaki Issei Takayama Shunin Hikage Noriko Katori Masahiko Kikuchi Hiroshi Sakai Yoshihiro Matsuda Formulation Technology Research Laboratories Daiichi Sankyo Co.Ltd.Kanagawa 254-0014Japan Department of Chemical System Engineering The University of TokyoTokyo 113-8656Japan Department of Systems Science Kyoto UniversityKyoto 606-8501Japan CMC Sciences Department Regulatory Affairs DivisionR&D DivisionJanssen Pharmaceutical K.K.Tokyo 101-0065Japan EuroTechno Ltd. Kanagawa 223-0057Japan Pharmaceutical Research Department Mitsubishi Tanabe Pharma CorporationOsaka 532-8505Japan Chemical Products CMC Regulatory Affairs Area Japan DevelopmentMSD K.K.Tokyo 102-8667Japan Graduate School of Pharmaceutical Sciences Kumamoto UniversityKumamoto 862-0973Japan Division of Drugs National Institute of Health SciencesKawasaki 210-9501Japan Technology Research&Development Sumitomo Dainippon Pharma Co.Ltd.Osaka 564-0053Japan Formulation Development Department Chugai pharmaceutical Co.Ltd.Tokyo 115-8543Japan Office of New Drug IV Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan Office of Generic Drugs Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan KOKANDO Co. Ltd.Toyama 930-8580Japan Pharmaceuticals and Medical Devices Agency Shin-Kasumigaseki Bldg.Tokyo 100-0013Japan

We presented a control strategy for tablet manufacturing processes based on continuous direct *** work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in *** different items in the process,the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch *** control and management of the loss in weight(LIW)feeder were deemed the most important,and the Residence Time Distribution(RTD)model were regarded effective for setting the control range and for controlling of the LIW *** on these ideas,the concept of process control using RTD was summarized.

关键词： Continuous manufacturing Solid drug products Process control Residence time distribution loss in weight feeder Regulatory science

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