SBIR Phase II: Continuous Manufacturing of Nano- and Micron-particle Drugs Using Focused Acoustics

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the enablement of new and improved therapeutic drug development. One hurdle in the development of new drugs, is their relatively low effectiveness due to poor water solubility limiting formulation choices and/or limiting cellular uptake. Forming drug nano particles, by way of controlling the drug crystal formation process, is one tool to overcome this low solubility hurdle. Acoustical energy has been shown to aid in the formation of drug crystallization however, current acoustical technologies are not able to reliably achieve the crystal size and distribution needed for many new drug candidates. A reliable method for nanoparticle drug production will allow better and more effective drugs to make it to market. Additionally, the Pharmaceutical industry is transitioning from batch to continuous flow manufacturing processes. This has significant impact on cost, responsiveness, and quality control of the drug supply chain, and will enable more rapid and lower cost drug development and manufacturing. The proposed project will develop equipment and processes that enable the continuous manufacture of drug nano and micron sized particles by controlling the crystallization using a novel focused acoustical field. Focused acoustics has the advantage of delivering a highly efficient, controllable, scalable energy field to the crystallization zone. The project will demonstrate a focused acoustics crystallization process capable of being developed into commercial grade equipment suitable for use in a continuous flow production pharmaceutical manufacturing environment.