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

圣约翰大学规划 IUCRC：医药产品综合材料科学与工程中心 (CIMSEPP)

• 批准号: 1841767
• 负责人: Abu Serajuddin
• 金额: $ 1.5万
• 依托单位: Saint John's University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-12-01 至 2019-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1841767&HistoricalAwards=false
• 关键词: Planning; IUCRC; St.; John; University

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.

美国的制药行业是一万亿美元的行业，对其人口的健康和福祉产生了巨大影响。 但是，与近年来在许多行业中的制造技术中取得的巨大进展不同，包括半导体，电子，汽车，食品，化学药品等，制药行业落后了。这种情况是，根据美国食品和药品管理局最近的公众评论和报告，即使在过去的半个世纪中，也没有太多创新的制药产品的创新。结果，美国面临着开发新药品，高毒品价格，许多质量和监管问题的高风险和成本，重要的是药物短缺。药物制造科学和技术缺乏进展可能主要是由于药品的高度复杂性质，这些产品由许多不同的组成部分组成，对制造过程的不同步骤所需的材料特性的理解不足以及预测工具不可利用的预测工具以基于材料特性评估产品性能。这个三大学中心将通过与制药行业的专家合作进行基础研究来召集一个工程和制药专家团队来解决这些问题。美国使用的药物中有80％以固体剂型形式，例如由颗粒和颗粒组成的片剂和胶囊。即使是许多注射或吸入的产品，也以颗粒形式生产。当前，对导致重大开发和制造问题的颗粒系统行为的理解不足，需要替代方法来表征它们并预测其性能。此外，在药物发现过程中合成的超过三分之二的新化学实体是非常不合理的，需要更新的技术来提高这种材料的溶解度，溶解速率和生物利用度。还需要创新技术来满足个性化药物的紧急需求，有针对性的药物输送和滥用药物（阿片类药物）。如果没有材料科学的进步，目前在其他行业中正常的制药行业中连续制造的实施也是不可能的。 圣约翰大学团队将通过在药品开发，新型药物输送系统和药品处理方面运用其广泛的专业知识来为解决这些问题做出贡献。该大学在其工业药学创新实验室中的现代最先进的设施，旨在利用有关晶体和颗粒工程，熔融挤出和颗粒化，纳米技术，喷雾干燥，3D打印和连续制造的研究。该奖项将反映出NSF的法定任务，并通过评估范围来反映出概念的支持者，该奖项已被评估概念和公差构成。