PFI-RP: Innovation of Materials Based on Sustainable Resources to Enhance Performance of Challenging Drugs and Drug Candidates.

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The broader impact/commercial potential of this PFI project is to enhance performance of the drugs that patients currently find on the pharmacist?s shelf, and to increase the number of effective new drugs that reach patients to treat critical medical issues. Currently up to 90% of drug candidates don?t fully dissolve in water, contributing to failure of otherwise effective candidates; all humans are roughly 70% water. We will design new materials, made from renewable resources and thus benign and environmentally sound, that solve key problems in drug delivery to patients. These currently unsolved problems include the inability to create patient-friendly formulations (pills) from drugs that require high doses (creating hard to swallow "horse pills"). Another important unsolved problem is failures of many drug candidates that tend to quickly form crystals from a water solution. When these drugs fail, cost of drug development goes up, which is ultimately passed along to patients. Drugs that would otherwise effectively treat diseases and are sorely needed by patients, never reach them. Our work will bring more drugs to patients, faster and more cheaply, and will reduce cost, side effects, dose, and variation in performance from patient to patient for drugs currently on the pharmacy shelf.The proposed project targets the design, preparation, and evaluation of two new families of materials prepared from natural cellulose, which is incredibly abundant, renewable, benign, and harvested in large quantities already from trees. These materials will be carefully designed so as to be easily made by current manufacturers of cellulose derivatives, and to work exceptionally well at enhancing the performance of drugs. They will be designed to help create solutions of current drugs, or drug candidates that are under development, that have far more dissolved drug per volume than is possible using current technologies. The ability to create these more concentrated solutions of drug or drug candidates in the human body will permit patients to get enough drug/drug candidate into their bloodstream to have the desired therapeutic effect, but at much lower drug dose. We will design, make, and characterize these materials, show that they work to create more concentrated solutions of key drugs, and figure out what features enhance their performance, so we can design even better materials. With our industrial partners, we will advance the best candidate materials towards commercialization so that they can benefit patients.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.