PFI-RP: Commercializing innovations in design and manufacture of fine pharmaceutical powders for cheaper and better medicines

The broader impact/commercial potential of this Partnerships for Innovation - Research Partnerships (PFI-RP) project is in making technologies available to improve manufacturing of powder-based products in a variety of industries, including pharmaceutical. These industries are increasingly dealing with fine powders, desirable because they improve product performance. Unfortunately, fine powder-based products pose significant difficulties in manufacturing and cause product failures due to their intrinsic poor processability and tendency to form large lumps. The innovation comes through scientific understanding of why fine powders behave poorly, and determining how their surfaces could be modified via novel mechanical processes to drastically and predictively improve their behavior. Significant commercial impact is expected from shorter drug product development times and reduced pharmaceutical product failures, as well as from increased profits in manufacturing tablet-based drug products. Societal impact comes from making available higher quality medicines to patients at lower costs. It will have a positive impact on the professional development of students participating in the project, through training in cutting-edge research, innovation and entrepreneurship. In addition, the proposed science teacher training will impact K-12 participants from school districts with large underrepresented minority populations. The proposed project will fundamentally advance understanding of how fine powders behave and why they lead to significant manufacturing challenges. The Intellectual merit of the project stems from physics-based models explaining why fine smooth particles, as well as rough particles (less than third the diameter of human hair), flow and pack poorly. However, when they are nano-rough, i.e., having surface asperities 500 times smaller than the diameter of human hair, they flow and pack significantly better. The understanding and development of mechanical processes to economically create nano-rough surfaces offer commercialization opportunities for the pharmaceutical industry. These include benefits from novel fine engineered drug powders flowing as well as those 5-10 times their size, and development of fine excipients that outperform their larger commercial counterparts in flow, packing, and tablet forming capability. The proposed novel advanced models should also help design the powders and their blends that form the building blocks of pharmaceutical products, such as tablets and capsules. If successful, these models will eliminate excessive time and material-consuming experimentation that increases manufacturing costs. Associated simulations will enable computer-assisted design of tablets, leading to better and cheaper drug products. Additional intellectual merit of the project is through the participation of students with industry partners and mentors while engaging in research targeted for commercialization.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.