SBIR Phase I: Continuous Manufacturing of Nanoparticle DrugS Using Focused Acoustics

这个小企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是实现新的和改进的治疗药物开发。 新药开发中的一个障碍是它们的有效性相对较低，这是由于水溶性差限制了制剂选择和/或限制了细胞摄取。 通过控制药物晶体形成过程形成药物纳米颗粒是克服这种低溶解度障碍的一种工具。 声能已被证明有助于药物结晶的形成，然而，目前的声学技术不能可靠地实现许多新的候选药物所需的晶体尺寸和分布。 一种可靠的纳米颗粒药物生产方法将使更好、更有效的药物进入市场。该项目将开发设备和工艺，通过使用新型聚焦声场控制结晶，实现药物纳米颗粒的连续生产。 聚焦声学的优点是向结晶区提供高效、可控、可扩展的能量场。 该项目将展示一种聚焦声学纳米颗粒化工艺，该工艺能够开发成适用于连续流生产制药环境的商业级设备。

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. The proposed project will develop equipment and processes that enable the continuous manufacture of drug nanoparticles 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 nanocrystallization process capable of being developed into commercial grade equipment suitable for use in a continuous flow production pharmaceutical manufacturing environment.