IUCRC Phase I UMN: Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP)

美国的制药业是一个主要的，万亿美元的产业，通过对美国人口的健康和福祉的好处，对他们产生广泛的影响。尽管美国处于领先地位，但该行业仍面临着重大问题，包括开发新分子的困难，将新药推向市场的成本高且时间长，缺乏充分有效的监管科学，消费者药物负担能力，质量问题和药物短缺。COVID-19大流行进一步加剧了其中许多挑战。这些问题表明迫切需要创新研究和技术进步，以开发高质量的药品，实现生产效率，并支持美国的制药业。这个IUCRC第一阶段项目通过建立一个联合两所大学的中心，为综合材料科学和工程的医药产品（CIMSEPP），与新泽西理工学院（NJIT）的领导网站和明尼苏达大学（UMN）作为合作伙伴网站解决这些问题。其使命是推进和促进对材料特性、分子和颗粒水平上的药物-添加剂相互作用以及生产工艺、产品质量和性能的基本理解，以更低的成本。CIMSEPP团队将在三个行业审查的研究重点下发展对药物产品和工艺工程的结构-功能-性能的基本理解：A）颗粒和晶体工程，B）材料和产品性能的模型预测理解，以及C）生物利用度增强和稳定性。 CIMSEPP的研究将1）促进药物，其工程对应物及其混合物的关键特性的预测增强，以提高产品质量，2）显着减少药物产品开发的时间和成本。 主要进展包括：1）识别影响细颗粒行为的关键颗粒特性，2）更好地了解它们对粉末凝聚力和行为的影响，以及3）能够准确预测混合物以及压实片剂的特性。这种理解将有助于开发有效制造更好产品所需的机械模型和预测工具。 UMN团队通过集成晶体工程和颗粒设计在粉末表征和性能增强方面的专业知识将1）能够开发高效和易于采用的策略来解决制造问题，2）通过长度尺度的系统研究，从分子尺寸到单晶/颗粒，再到粉末，该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The pharmaceutical sector in America is a major, trillion-dollar industry, having broad impacts on the US population through benefits to their health and well-being. Despite US leadership, the industry is facing major problems, including, difficulties in developing newer molecules, high cost and lengthy time of bringing a new drug to market, lack of adequate and efficient regulatory science, consumer drug affordability, quality issues, and drug shortages. The COVID-19 pandemic has further exacerbated many of these challenges. These issues point to an acute need for innovative research and technical advances to develop high-quality drug products, achieve manufacturing efficiency, and support US-based pharmaceutical manufacturing. This IUCRC phase I project addresses such issues through establishing a joint two-university Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP), with New Jersey Institute of Technology (NJIT) as the Lead Site and University of Minnesota (UMN) as a Partner Site. Its mission is to advance and promote fundamental understanding of the material properties, drug-additive interactions at molecular and particulate level, as well as manufacturing processes, on product quality and performance, at lower cost.The CIMSEPP team will develop fundamental understanding of structure-function-performance of drug products and process engineering under three industry vetted Research Thrusts: A) Particle and Crystal Engineering, B) Model Predictive Understanding of Materials and Product Performance, and C) Bioavailability Enhancement and Stability. Research at CIMSEPP will 1) promote predictive enhancement of key properties of drugs, their engineered counterparts, and their blends for improving product quality, and 2) significantly reduce time and cost of drug product development. Key advances include, 1) identification of critical particle properties that impact fine particle behavior, 2) better understanding of their impact on cohesion and behaviors of powders, and 3) enabling accurate prediction of properties of blends as well as compacted tablets. That understanding will enable the development of mechanistic models and predictive tools required for efficient manufacturing of better products. The UMN team’s expertise in powder characterization and property enhancement through integrated crystal engineering and particle design will 1) enable the development of both highly effective and easy-to-adopt strategies to solve manufacturing problems and 2) contribute to the fundamental understanding of structure – property relationship through systematic research at length scales, ranging from molecular dimension to single crystal/particles, to powders, and to finished products.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.