This Small Business Innovation Research (SBIR) Phase I project proposes to develop a flexible platform for nano-formulations of water insoluble drugs. As the practice of medicine progresses towards "complete cure for diseases", delivering new drugs to specific areas to target specific tissues becomes an important objective of overall pharmaceutical research. Unfortunately many new drugs have poor water solubility that reduces their bioavailability. Carefully formulated nanoparticles and nanospheres are reported to have therapeutic advantages such as bioavailability, ability to avoid reticuloendothelial system (RES) removal, and direct tumor targeting. This project will develop the Supercritical Anti-Solvent with Enhanced Mass Transfer (SAS-EM) Process for producing nanoparticles of water insoluble drugs and encapsulating them in biodegradable polymers as nanospheres. The three key steps in the Phase I study include : (1) Phase behavior studies to identify the suitable solvent and experimental conditions, (2) Particle formation studies where nanoparticles of said drugs are produced using supercritical antisolvent process with enhanced mass transfer, and (3) Characterization of the nanoparticles/nanospheres for particle size, size distribution, and crystallinity. Light scattering techniques will be used to measure the size distribution complemented with Scanning electron microscopic visualization. X-ray diffraction measurements will be used to describe the crystallinity. The commercial applications of this project are in the area of pharmaceutical drug delivery
