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

Purdue University, West Lafayette IN

Investigators

Abstract

0941302 Reklaitis Intellectual Merit The 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 Impact The 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.