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

IUCRC 第一期 NJIT：医药产品综合材料科学与工程中心 (CIMSEPP)

• 批准号: 2137209
• 负责人: Rajesh Dave
• 金额: $ 91万
• 依托单位: New Jersey Institute of Technology
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2137209&HistoricalAwards=false
• 关键词: IUCRC; Phase; NJIT; Center; Integrated

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 NJIT as a Lead Site and Minnesota 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, which 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 combined with particle and crystal engineering, will enable development of mechanistic models and predictive tools required for enabling manufacturing decisions and better products. NJIT’s expertise in particle engineering and 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. Compared to the data-driven approaches, such models and computer simulations for process modeling, will enable better understanding of traditional and emerging technologies, promoting efficient design of high-quality products and manufacturing processes, while reducing time and cost for product and scalable process development.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NJIT作为一个领导网站和明尼苏达州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的基本理解，以更低的成本实现产品质量和性能。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，1）促进药物、其工程对应物及其混合物的关键性质的预测性增强，以提高产品质量，以及2）显著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。这种理解与颗粒和晶体工程相结合，将有助于开发制造决策和更好产品所需的机械模型和预测工具。 NJIT在颗粒工程和接触物理学方面的专业知识将使颗粒团聚，药物含量均匀性和片剂重量变化的预测模型的开发使用无量纲参数（S）的基础上，材料节省测量颗粒特性，如大小，形状和粗糙度。与数据驱动的方法相比，用于过程建模的此类模型和计算机模拟将使人们能够更好地理解传统和新兴技术，促进高质量产品和制造工艺的高效设计，该奖项反映了NSF的法定使命，并被认为是值得通过使用基金会的智力价值进行评估来支持的和更广泛的影响审查标准。

项目成果

Enhanced blend uniformity and flowability of low drug loaded fine API blends via dry coating: The effect of mixing time and excipient size

通过干包衣增强低载药量精细 API 混合物的混合均匀性和流动性：混合时间和赋形剂尺寸的影响

• DOI: 10.1016/j.ijpharm.2023.122722
• 发表时间: 2023
• 期刊: International Journal of Pharmaceutics
• 影响因子: 5.8
• 作者: Kim, Sangah S.;Castillo, Chelsea;Cheikhali, Mirna;Darweesh, Hadeel;Kossor, Christopher;Davé, Rajesh N.
• 通讯作者: Davé, Rajesh N.

Preparation of Free-Flowing Spray-Dried Amorphous Composites Using Neusilin®

使用 Neusilin® 制备自由流动的喷雾干燥非晶复合材料

• DOI: 10.1208/s12249-023-02511-0
• 发表时间: 2023
• 期刊: AAPS PharmSciTech
• 影响因子: 3.3
• 作者: Lin, Zhixing;Zheng, Kai;Azad, Mohammad A.;Davé, Rajesh N.
• 通讯作者: Davé, Rajesh N.

On predicting the performance of different silicas on key property enhancements of fine APIs, blends, and tablets

预测不同二氧化硅对精细 API、混合物和片剂关键性能增强的性能

• DOI: 10.1016/j.powtec.2023.119104
• 发表时间: 2024
• 期刊: Powder Technology
• 影响因子: 5.2
• 作者: Kim, Sangah S.;Seetahal, Ameera;Kossor, Christopher;Davé, Rajesh N.
• 通讯作者: Davé, Rajesh N.

Impact of Silica Dry Coprocessing with API and Blend Mixing Time on Blend Flowability and Drug Content Uniformity

二氧化硅与 API 干法协同处理和共混物混合时间对共混物流动性和药物含量均匀性的影响

• DOI: 10.1016/j.xphs.2023.05.016
• 发表时间: 2023
• 期刊: Journal of Pharmaceutical Sciences
• 影响因子: 3.8
• 作者: Kim, Sangah S.;Seetahal, Ameera;Amores, Nicholas;Kossor, Christopher;Davé, Rajesh N.
• 通讯作者: Davé, Rajesh N.

Selection of Silica Type and Amount for Flowability Enhancements via Dry Coating: Contact Mechanics Based Predictive Approach

选择二氧化硅类型和用量以通过干涂增强流动性：基于接触力学的预测方法

• DOI: 10.1007/s11095-023-03561-6
• 发表时间: 2023
• 期刊: Pharmaceutical Research
• 影响因子: 3.7
• 作者: Kunnath, Kuriakose T.;Tripathi, Siddharth;Kim, Sangah S.;Chen, Liang;Zheng, Kai;Davé, Rajesh N.
• 通讯作者: Davé, Rajesh N.