近年の製薬プロセスに求められている合理化、品質確保、省エネ等に対して、薬学、工学の観点から検討を進め、問題解決および進展を目指す。特に、今後日本の製薬プロセスにも取り入れられていくことが大きく期待されている連続生産に関しては、代表的なプロセスである混合・造粒・乾燥プロセスの統合を中心に検討し、医薬品連続生産の導入・発展に寄与することを目的とする。また、これまで構築してきた新規製剤開発のための粒子設計、特性解析・制御のための研究成果をさらに発展させるとともに、生産プロセスを視野に入れた研究へと展開する。連続生産の研究には、製剤工学、粉体工学、化学工学等の基盤領域に加え、産学の連携をも活用した新たな基盤構築が必要である。 2018年に立ち上げた連続生産の実現・推進を考える会（CCPMJ：Consortium on Continuous Pharmaceutical Manufacturing, Japan：http://ccpmj.org/about/）1 ）の活動推進拠点として、薬・工、産・学の情報交換の場を提供し、多角的な連携構築を目指す。医薬品開発動向にも留意し連続生産が注目されているバイオ医薬品生産との連携も図る。これらの活動により、本学における新しい薬学教育にも貢献し、国内での製薬工業の振興に寄与することを目指す。
Our research team aims to solve issues and develop in terms of rationalization, quality assurance and energy saving required for recent pharmaceutical processes from the viewpoint of pharmaceutical science and engineering. We would especially like to contribute to the introduction and development on Pharmaceutical Continuous Manufacturing, which is highly-expected to be taken into the pharmaceutical process soon in Japan, and we will focus on integration of the typical processes such as mixing, granulation, and drying. In addition, we will advance the research results on particle design, characterization and control for the development of novel pharmaceuticals that we have been building up to now, and expand into researchs with a view to the manufacturing process. For continuous manufacturing research, it is necessary to construct a new foundation utilizing industry-academia cooperation in addition to the basic areas of pharmaceutical engineering, powder engineering, chemical engineering and others. As a base for promoting activities of CCPMJ: Consortium on Continuous Pharmaceutical Manufacturing, Japan launched in 2018, we aim to establish a multifaceted collaboration by providing a forum for exchanging information on medicine, engineering, industry and academia. We also pay attention to drug development trends, and cooperate with biopharmaceutical production where continuous manufacturing is drawing attention. Through these activities, we would like to contribute to both new pharmaceutical education at our university and the promotion of the Japanese pharmaceutical industry.
研究課題 Research Objectives
製薬プロセスの合理化、製品品質確保に寄与する研究 Studies on pharmaceutical process contributing to streamline and ensuring of product quality
固形製剤連続生産のための工学的研究 Engineering studies on continuous manufacturing of solid dosage forms
連続プロセス構築のための医薬品および添加剤の粒子設計と評価 Particle design and evaluation for continuous manufacturing of pharmaceutical products and excipients
口腔内崩壊錠、フィルム製剤等の新規固形製剤の生産プロセスに関する研究 Engineering studies on manufacturing of novel solid dosage forms such as rapidly disintegrating tablets and films
最近の研究成果 Research Results
Takahashi T., Toyota H., Kuroiwa Y., Kondou H., Dohi M., Hakomori T., Nakamura M., Takeuchi H. Application of novel compaction indicator for the optimization of compaction conditions based on a compaction simulation study. Int J Pharm. 587, 119574 (2020).
Takeuchi Y., Murase, K. Tahara, Takeuchi H., Impact of surface roughness of pre-treated punches and powder properties on prevention of sticking during pharmaceutical tableting, J. Drug. Delivery Sci. Technol., 60, 10199 (2020).
Tomita Y., Takeuchi Y., Natsuyama, S., Takeuchi H., Characteristics of residence time distribution in a continuous high shear mixer granulation using scraper rotation, Int. J. Pharm., 605, 120789 (2021).
Takeuchi Y., Hyakawa F., Tahara K., Takeuchi H., Orally disintegrating films: The effects of water content on disintegration and mechanical properties, J. Drug Del. Sci., Technol., 66, 102893 (2021).
