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

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

基本信息

批准号：
2137264
负责人：
Changquan Sun
金额：
$ 59万
依托单位：
University of Minnesota-Twin Cities
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 2027-02-28
项目状态：
未结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=2137264&HistoricalAwards=false
关键词：
IUCRC Phase UMN Center Integrated

项目摘要

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 New Jersey Institute of Technology (NJIT) as the Lead Site and University of Minnesota (UMN) 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: A) Particle and Crystal Engineering, B) Model Predictive Understanding of Materials and Product Performance, and C) Bioavailability Enhancement and Stability. Research at CIMSEPP 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 will enable the development of mechanistic models and predictive tools required for efficient manufacturing of better products. The UMN team’s expertise in powder characterization and property enhancement through integrated crystal engineering and particle design will 1) enable the development of both highly effective and easy-to-adopt strategies to solve manufacturing problems and 2) contribute to the fundamental understanding of structure – property relationship through systematic research at length scales, ranging from molecular dimension to single crystal/particles, to powders, and to finished products.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个主要的，万亿美元的行业，通过对健康和福祉的利益对美国人口产生广泛影响。尽管美国领导层，该行业仍面临重大问题，包括在开发新分子，高成本和将新药推向市场的漫长时间，缺乏足够有效的监管科学，消费者药物可用性，质量问题和药物短缺的困难。 Covid-19-大流行进一步加剧了许多此类挑战。这些问题表明，急需创新研究和技术进步，以开发高质量的药品，达到制造效率并支持美国的药品制造。该IUCRC I期项目通过建立新泽西理工学院（NJIT）作为领导地点和明尼苏达大学（UMN）作为合作伙伴地点的新泽西理工学院（NJIT），以建立制药产品集成材料科学和工程联合综合材料科学与工程中心解决此类问题。它的任务是提高和促进对材料特性的基本理解，分子和颗粒水平上的药物添加相互作用以及制造过程，产品质量和性能，以较低的成本。CIMSEPP团队将在三个行业的兽医研究中对药物和过程工程的结构功能 - 材料的构图和制作粒子的构图和水晶工程的构图，b）建立对结构 - 官能产品的结构功能 - 效果：生物利用度增强和稳定性。 CIMSEPP的研究将1）促进药物的关键特性，其工程对应物以及提高产品质量的混合物的预测性增强，以及2）显着降低药物产品开发的时间和成本。关键进展包括1）识别影响细粒子行为的临界粒子特性，2）更好地理解它们对粉末的凝聚力和行为的影响，以及3）实现对混合物和压实平板电脑的特性的准确预测。这种理解将使能够开发有效制造更好产品所需的机械模型和预测工具。 UMN团队通过集成的晶体工程和粒子设计在粉末表征和财产增强方面的专业知识1）启用高效且易于使用的策略，以解决制造问题，2）有助于通过分子尺寸到统计范围的范围，以及成熟的产品，再到成熟的产品，以及型号，以及贡献的产品，以及型号，以及促成型号，以及贡献产品，以及促销产品，以及促成型号，以及贡献的产品，以及贡献的产品，以及促销产品，以及促成了型号，以及对结构的基本了解，并促进了型号，并促进了型号，并促进了型号，并促进了型号，以及贡献的产品，以及促销产品，以及促销级别，促销级别，促成了诸如级别的范围。使用基金会的知识分子优点和更广泛的审查标准，通过评估被认为值得支持。

项目成果

期刊论文数量（14）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Effect of drug loading and relative humidity on the mechanical properties and tableting performance of Celecoxib–PVP/VA 64 amorphous solid dispersions

载药量和相对湿度对塞来昔布·PVP/VA 64无定形固体分散体机械性能和压片性能的影响

DOI：
10.1016/j.ijpharm.2023.123337
发表时间：
2023
期刊：
International Journal of Pharmaceutics
影响因子：
5.8
作者：
Osei-Yeboah, Frederick;Sun, Changquan Calvin
通讯作者：
Sun, Changquan Calvin

Stress transmission coefficient is a reliable and robust parameter for quantifying powder plasticity

应力传递系数是量化粉末塑性的可靠且稳健的参数

DOI：
10.1016/j.powtec.2021.117066
发表时间：
2022
期刊：
Powder Technology
影响因子：
5.2
作者：
Vreeman, Gerrit;Sun, Changquan Calvin
通讯作者：
Sun, Changquan Calvin

Understanding the role of magnesium stearate in lowering punch sticking propensity of drugs during compression

了解硬脂酸镁在降低压缩过程中药物冲头粘连倾向方面的作用

DOI：
10.1016/j.ijpharm.2023.123016
发表时间：
2023
期刊：
International Journal of Pharmaceutics
影响因子：
5.8
作者：
Gunawardana, Chamara A.;Kong, Angela;Wanapun, Debbie;Blackwood, Daniel O.;Travis Powell, C.;Krzyzaniak, Joseph F.;Thomas, Myles C.;Kresevic, John E.;Sun, Changquan Calvin
通讯作者：
Sun, Changquan Calvin

Air entrapment during tablet compression – Diagnosis, impact on tableting performance, and mitigation strategies

片剂压缩过程中的空气滞留 — 诊断、对压片性能的影响以及缓解策略