CDI-Type II: Cyber-enabled engineering of pharmaceutical products

CDI-Type II：医药产品的网络工程

• 批准号: 0941302
• 负责人: Gintaras Reklaitis
• 金额: $ 193.28万
• 依托单位: Purdue University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-10-01 至 2014-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0941302&HistoricalAwards=false
• 关键词: CDI; Type; II; Cyber; enabled

0941302ReklaitisIntellectual MeritThe long time and high cost of translating a newly discovered drug to a drug product that will have the desired performance properties when taken by the patient, are significant factors contributing to the high price of new drugs. The work requires designing the right combination and form of ingredients as well as efficient and robust manufacturing processes. These activities are now carried out largely by trial and error means using traditional equipment and relying on past experience. It is widely recognized by the industry and academia that to change the current mode requires new fundamental science and engineering understanding, new engineering methods and computer-based predictive tools. Additionally, the industry needs a workforce that is trained in these new methods and tools to accelerate the desired transformation. This project will address both of these needs. It will create a representative set of tools, methods and education materials and build a hub technology, called pharmaHUB for sharing and growing the technology through virtual collaboration. The project will implement a library of predictive models for the design and operation of the most important tablet manufacturing operations, will develop computer-based models for predicting how a drug product, such as a tablet, will break apart and dissolve, and will build virtual patient population models that can be used to predict how effectively a specific drug is transported within the body. The use of this methodology will be demonstrated through case studies with five specific drug products. Based on NSF sponsored HUBzero middleware, pharmaHUB will provide open access via the web and internet to all of the created and contributed tools, methods and education content, allowing easy downloading or direct execution of applications on the server farm. It will also allow researchers in the field to easily upload and install their developments, lectures and educational materials in a simple and transparent fashion thus dramatically accelerating community knowledge growth. The project will draw from the results generated in research efforts such as the NSF ERC on Structured Organic Particulate Systems as well as the work of the National Institute for Pharmaceutical Technology and Education, in which the co-pi's are actively involved. Broader ImpactThe tools and associated education materials, openly accessible on pharmaHUb, will serve as core components of new courses and degree programs in pharmaceutical engineering suitable for both students and professionals.

将新发现的药物转化为患者服用时具有所需性能的药物产品的时间长且成本高，是导致新药价格高的重要因素。这项工作需要设计正确的成分组合和形式，以及高效和强大的制造工艺。这些活动现在主要是通过使用传统设备和依靠过去经验的试错手段进行的。业界和学术界普遍认识到，要改变目前的模式，需要新的基础科学和工程理解、新的工程方法和基于计算机的预测工具。此外，该行业需要一支受过这些新方法和工具培训的员工队伍，以加速所需的转型。该项目将满足这两方面的需求。它将创建一套具有代表性的工具、方法和教育材料，并建立一个名为pharmaHUB的中心技术，通过虚拟协作共享和发展技术。该项目将实施一个预测模型库，用于最重要的片剂制造操作的设计和操作，将开发基于计算机的模型，用于预测药物产品（如片剂）如何分解和溶解，并将建立虚拟患者群体模型，可用于预测特定药物在体内的运输效率。将通过对五种特定药品的案例研究来证明这种方法的使用。 基于NSF赞助的HUBzero中间件，pharmaHUB将通过Web和互联网提供对所有创建和贡献的工具，方法和教育内容的开放访问，允许轻松下载或直接执行服务器群上的应用程序。它还将使该领域的研究人员能够以简单透明的方式轻松上传和安装他们的开发成果、讲座和教育材料，从而大大加快社区知识的增长。该项目将借鉴在研究工作中产生的结果，如NSF ERC关于结构化有机颗粒系统以及国家制药技术和教育研究所的工作，其中co-pi积极参与。 更广泛的影响这些工具和相关的教育材料，可在pharmaHUb上公开访问，将作为适合学生和专业人士的制药工程新课程和学位课程的核心组成部分。