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

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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.