Planning IUCRC at NJIT Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP)

国际自然与自然保护委员会的规划项目重点是建立一个三所大学合作的中心，以推进基础材料科学和工程研究，促进高质量药物产品的开发。制药行业在美国是一个重要的，万亿美元的产业，对其人口的健康和福祉有着广泛的影响。然而，也存在一些重大问题，例如，市场增长放缓、新药上市时间长且成本高、产品质量和监管问题以及药品短缺。这主要是由于药品的高度复杂性，其中包含许多不同的成分，对制造过程的理解不足，以及缺乏从材料特性评估产品性能的预测工具。本中心旨在解决这些问题和行业的需求，通过范式转换机制的方法，以发展对工艺和材料性能对产品性能影响的预测性理解。拟议的基于材料科学的转化研究有望产生重大的经济影响，因为它提高了产品质量，减少了产品故障，简化了制造操作，并显著减少了产品开发时间和制造成本。该中心还将通过尖端研究方法、技术转让、创新和创业方面的培训，对代表性不足的少数群体的学生产生积极影响。提出的研究旨在发展对颗粒基药物产品的结构-功能-性能及其工艺工程的基本理解，为应用晶体和颗粒工程来提高药物的生物利用度、可制造性、产品稳定性和产品质量铺平道路。中心的研究重点是：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。三个CIMSEPP团队将推进对受制造工艺影响的分子/颗粒水平上药物和添加剂之间的材料特性和相互作用的理解。NJIT在颗粒接触物理方面的专业知识将有助于开发颗粒团聚、药物含量均匀性和片剂重量变化的预测模型，该模型使用基于颗粒性质（如大小、形状和粗糙度）的材料节约测量的无量纲参数。在颗粒过程建模方面的专业知识，例如混合，涂层和干燥，采用离散元方法，人口平衡建模和多相CFD，将使人们更好地理解传统和新兴技术，如薄膜和3D打印。中心范围内的合作将带来改善药物溶解度、溶出率和生物利用度、个性化药物和儿科剂量的技术，同时减少产品设计、工艺开发、扩大规模的时间，并实现连续生产。该奖项反映了美国国家科学基金会的法定使命，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。

This IUCRC planning project focuses on establishing a collaborative three-university center to advance fundamental materials science and engineering research for facilitating high quality drug product development. The pharmaceutical sector in the USA is a major, trillion-dollar industry, having broad impacts on the health and well-being of its population. Yet, there are major problems, e.g., slowing market growth, long time and high costs of bringing a new drug to market, product quality and regulatory issues, and drug shortages. These arise largely due to highly complex nature of pharmaceutical products, which contain many different components, the inadequate understanding of the manufacturing processes, and lack of predictive tools to assess product performance from material properties. This Center aims to address these problems and the needs of industry through paradigm shifting mechanistic approach for developing predictive understanding of the impact of processes and material properties on product performance. Proposed material science based translational research is expected to have significant economic impact, due to improved product quality, reduced product failures, simplified manufacturing operations, and significantly reducing product development times and manufacturing costs. The Center will also positively impact students from under-represented minority groups, through training in cutting edge research methodologies, tech-transfer, innovation and entrepreneurship.The proposed research aims at developing a fundamental understanding of structure-function-performance of particulate-based drug products and their process engineering, paving the way for applying crystal and particle engineering towards enhancing drug bioavailability, manufacturability, product stability, and product quality. Center research thrusts, designed for transformative impact, are: A) Particle and Crystal Engineering, B) Model Predictive Understanding of Materials and Product Performance, and C) Bioavailability Enhancement and Stability. Tre CIMSEPP team will advance understanding of the material properties and interactions among drug(s) and additives at the molecular/particulate level as affected by manufacturing processes. NJIT's expertise in particle contact-physics will enable development of predictive models for particle agglomeration, drug content uniformity, and tablet weight variation using dimensionless parameter(s) based on material sparing measurements of particle properties such as size, shape, and roughness. Expertise in modeling of particle processes, e.g., mixing, coating, and drying, employing discrete element method, population balance modeling, and multi-phase CFD, will enable better understanding of traditional and emerging technologies, such as thin films and 3D printing. Center-wide collaborations will lead to technologies for improved drug solubility, dissolution rate and bioavailability, personalized medicines and pediatric dosing, while reducing time for product design, process development, scale-up, as well as enabling continuous manufacturing.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.