Control strategy and methods for continuous direct compression processes
We presented a control strategy for tablet manufacturing processes based on continuous direct compression. The work was conducted by the experts of pharmaceutical companies, machine suppliers, academia, and regulatory authority in Japan. Among different items in the process, the component ratio and...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-03-01
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| Series: | Asian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1818087620314616 |
| _version_ | 1818415820209913856 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Yasuhiro Suzuki |
| collection | DOAJ |
| description | We presented a control strategy for tablet manufacturing processes based on continuous direct compression. The work was conducted by the experts of pharmaceutical companies, machine suppliers, academia, and regulatory authority in Japan. Among 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 manufacturing. The 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 feeder. Based on these ideas, the concept of process control using RTD was summarized. The presented contents can serve as a solid fundament for adopting a new control method of continuous direct compression processes in and beyond the Japanese market. |
| first_indexed | 2024-12-14T11:41:04Z |
| format | Article |
| id | doaj.art-1bde5854bc714e778aed4f7c947946d0 |
| institution | Directory Open Access Journal |
| issn | 1818-0876 |
| language | English |
| last_indexed | 2024-12-14T11:41:04Z |
| publishDate | 2021-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Asian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-1bde5854bc714e778aed4f7c947946d02022-12-21T23:02:49ZengElsevierAsian Journal of Pharmaceutical Sciences1818-08762021-03-01162253262Control strategy and methods for continuous direct compression processesYasuhiro Suzuki0Hirokazu Sugiyama1Manabu Kano2Ryutaro Shimono3Gosuke Shimada4Ryoichi Furukawa5Eichi Mano6Keiichi Motoyama7Tatsuo Koide8Yasuhiro Matsui9Kazuki Kurasaki10Issei Takayama11Shunin Hikage12Noriko Katori13Masahiko Kikuchi14Hiroshi Sakai15Yoshihiro Matsuda16Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Kanagawa 254-0014, Japan; Corresponding author.Department of Chemical System Engineering, The University of Tokyo, Tokyo 113-8656, JapanDepartment of Systems Science, Kyoto University, Kyoto 606-8501, JapanCMC Sciences Department, Regulatory Affairs Division, R&D Division, Janssen Pharmaceutical K.K., Tokyo 101-0065, JapanEuroTechno Ltd., Kanagawa 223-0057, JapanPharmaceutical Research Department, Mitsubishi Tanabe Pharma Corporation, Osaka 532-8505, JapanChemical Products, CMC Regulatory Affairs Area Japan Development, MSD K.K., Tokyo 102-8667, JapanGraduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto 862-0973, JapanDivision of Drugs, National Institute of Health Sciences, Kawasaki 210-9501, JapanTechnology Research & Development, Sumitomo Dainippon Pharma Co.,Ltd., Osaka 564-0053, JapanFormulation Development Department, Chugai pharmaceutical Co., Ltd., Tokyo 115-8543, JapanOffice of New Drug IV, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., Tokyo 100-0013, JapanOffice of Generic Drugs, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., Tokyo 100-0013, JapanDivision of Drugs, National Institute of Health Sciences, Kawasaki 210-9501, JapanGraduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto 862-0973, JapanKOKANDO Co., Ltd., Toyama 930-8580, JapanPharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., Tokyo 100-0013, JapanWe presented a control strategy for tablet manufacturing processes based on continuous direct compression. The work was conducted by the experts of pharmaceutical companies, machine suppliers, academia, and regulatory authority in Japan. Among 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 manufacturing. The 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 feeder. Based on these ideas, the concept of process control using RTD was summarized. The presented contents can serve as a solid fundament for adopting a new control method of continuous direct compression processes in and beyond the Japanese market.http://www.sciencedirect.com/science/article/pii/S1818087620314616Continuous manufacturingSolid drug productsProcess controlResidence time distributionLoss in weight feederRegulatory science |
| spellingShingle | 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 Control strategy and methods for continuous direct compression processes Asian Journal of Pharmaceutical Sciences Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder Regulatory science |
| title | Control strategy and methods for continuous direct compression processes |
| title_full | Control strategy and methods for continuous direct compression processes |
| title_fullStr | Control strategy and methods for continuous direct compression processes |
| title_full_unstemmed | Control strategy and methods for continuous direct compression processes |
| title_short | Control strategy and methods for continuous direct compression processes |
| title_sort | control strategy and methods for continuous direct compression processes |
| topic | Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder Regulatory science |
| url | http://www.sciencedirect.com/science/article/pii/S1818087620314616 |
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