SBIR Phase I: Dense Nanolipid Fluids (DNLFs) for Delivery of Drugs with Poor Bioavailability: Synthesis, Manufacture, and Drug Properties

The broader impact /commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to care for patients suffering from diseases including diabetes, multiple Sclerosis (MS), acquired immunodeficiency syndrome (AIDS), and cancer using nano dosage forms of drug molecules. Making drugs nano-sized helps them be absorbed and move to parts of the body where needed. The ability to manufacture nanosized drugs comes from the discovery that drug sizes may be decreased with a twin screw extruder, a type of machine usually used to produce bulk products such as plastic pipes, garbage bags, snack foods, cereal, and pasta. Before the discovery of the twin screw extruder, drug nanoparticles were only made in thimbleful quantities and were prohibitively expensive. This NSF SBIR Phase I project seeks to tap the potential of nano-sized drug forms by allowing them to be made economically and getting them into the hands of medical researchers. This Small Business Innovation Research (SBIR) Phase I project seeks to provide new knowledge related to surfactant-lipid-water systems and drug delivery nanoparticles. Although there has been much research focused on increasing the body’s absorption of drugs using lipid nanoparticles, translation to the clinic has been limited because nanoparticles cannot be produced with sufficient reproducibility, quality, or in sufficient quantities, making them prohibitively expensive. This SBIR project seeks to solve these problems by using twin-screw extrusion, a process typically used for bulk manufacturing of commodity goods such as plastic pipes, garbage bags, snack foods and pasta. The twin screw extruder process is based on the transient formation of rupturable surfactant-lipid-water mesophases during transit through the extruder barrel. To be successful at the twin screw extrusion of drug nano dosage forms, new scientific knowledge must be created to advance conceptualization of surfactant-lipid-water systems from time invariant equilibrium structures to highly time dependent dynamic non-equilibrium processes.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.