Planning IUCRC at St. John's University: Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP)

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The pharmaceutical sector in the USA, a trillion-dollar industry, has tremendous impacts on the health and well-being of its population. However, unlike the enormous progress made in manufacturing technologies in recent years in many industries, including semiconductor, electronics, automotive, food, chemicals, etc., the pharmaceutical industry has lagged much behind. The situation is such that, according to recent public comments and reports by the US Food and Drug Administration, there has not been much innovations in how pharmaceutical products are developed and manufactured even during the past half a century. As a consequence, the US is facing very high risk and cost of developing new drug products, high drug prices, many quality and regulatory issues, and, importantly, drug shortages. The lack of progress in pharmaceutical manufacturing sciences and technologies could primarily be due to highly complex nature of pharmaceutical products that consist of numerous different components, the inadequate understanding of material properties necessary at different steps of the manufacturing process, and non-availability of predictive tools to assess product performance based on material properties. This three-university center will bring together a team of engineering and pharmaceutical experts to address these problems by conducting fundamental research in partnership with experts from pharmaceutical industry. Over 80 percent of medicines used in the USA are in solid dosage forms, such as tablets and capsules that consist of granules and particles. Even many products that are injected or inhaled are produced as particulates. Currently, there is poor understanding of the behavior of particulate systems resulting in major development and manufacturing issues, and alternative approaches are needed to characterize them and predict their performance. Additionally, over two-thirds of new chemical entities synthesized during drug discovery are extremely water-insoluble and newer technologies are needed to improve solubility, dissolution rate and bioavailability of such materials. Innovstive technologies are also needed to address the urgent needs of personalized medicines, targeted drug delivery, and abuse-deterrent medications (opioids). Implementation of continuous manufacturing in pharmaceutical industry, which is currently normal in other industries, is also not possible without advancement in materials sciences. The St. John's University team will contribute to resolving these issues by applying its extensive expertise in drug product development, novel drug delivery systems, and pharmaceutical processing. The university's modern state-of-the-art facilities in its Industrial Pharmacy Innovation Laboratory to conduct research on crystal and particulate engineering, melt extrusion and granulation, nanotechnology, spray drying, 3D printing and continuous manufacturing will be utilized.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.