Suzuki Yasuhiro, Sugiyama Hirokazu, Kano Manabu, Shimono Ryutaro, Shimada Gosuke, Furukawa Ryoichi, Mano Eichi, Motoyama Keiichi, Koide Tatsuo, Matsui Yasuhiro, Kurasaki Kazuki, Takayama Issei, Hikage Shunin, Katori Noriko, Kikuchi Masahiko, Sakai Hiroshi, Matsuda Yoshihiro
Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Kanagawa 254-0014, Japan.
Department of Chemical System Engineering, The University of Tokyo, Tokyo 113-8656, Japan.
Asian J Pharm Sci. 2021 Mar;16(2):253-262. doi: 10.1016/j.ajps.2020.11.005. Epub 2020 Dec 8.
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.
我们提出了一种基于连续直接压片的片剂制造工艺控制策略。这项工作由日本制药公司、机器供应商、学术界和监管机构的专家共同开展。在该工艺的不同项目中，成分比例和混合粉末含量被选为需要不同于传统批量生产的连续制造特定控制方法的项目。失重（LIW）进料器的控制和管理被认为是最重要的，停留时间分布（RTD）模型被视为对设定控制范围和控制LIW进料器有效。基于这些理念，总结了使用RTD进行过程控制的概念。所呈现的内容可为日本国内外采用连续直接压片工艺的新控制方法提供坚实基础。
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