SBIR Phase I: A novel nanoformulation drug delivery platform to overcome poorly soluble drug challenges.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project accelerates drug development. The proposed method of producing preclinical drug formulations will accelerate and improve the success rate of drug development for a variety of disease areas where existing methods have not yet proven to be effective. Currently, the average wait time for a researched drug to reach patients at scale is 10-12 years, with only a 0.0002% approval rating. The proposed technology uses nanoparticles without additional chemicals or solvents, a mechanism that is versatile and adaptable for many drug delivery forms. In addition to accelerating drug development it enables new therapeutics currently administered in clinical settings. This Small Business Innovation Research (SBIR) Phase I project creates a platform to overcome poorly soluble drug formulation and delivery challenges. While great progress has been made in developing drug candidates, still the majority are insoluble in water (>80%) and have low bioavailability, resulting in 40% failed preclinical studies due to improper formulations. This project develops and validates a nanoparticle compound generation platform that improves the bioavailability of poorly soluble drugs. The specific work will: (1) Identify the critical technology platform parameters for robust nanoparticle generation at scale; (2) Explore the delivery properties of various nanoparticle drug carriers; and (3) Improve the measurement accuracy of a nanodrug dissolution assay. 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.