SBIR Phase I: Automated Analyzer for Drug Delivery Systems

这项小企业创新研究第一阶段（SBIR）项目将开发一种新型的实时气溶胶质谱仪（ams），用于分析肺部给药系统中的可吸入粉末和液体气溶胶。三个参数控制药物向肺部的有效递送：(1)单位体积可吸入液体携带的气溶胶颗粒的数量密度；(2)粒径分布；(3)有效成分浓度与粒径的函数关系。气溶胶质谱仪，通过适当的校准，可以同时测量这三个参数。Aerodyne研究公司（ARI）与几个大学研究小组合作，开发、演示并商业化了一种创新的定量AMS系统。通过适当的修改和校准，该系统可以大大减少表征肺部给药系统所需的时间和精力，无论是研究还是生产质量保证。这个第一阶段的项目将设计和测试一个实时AMS系统，以表征新的肺部给药系统。该项目的主要商业应用将在肺给药分析仪市场。潜在客户可能包括药物输送公司、制药公司、学术研究组织和监管机构。

This Small Business Innovation Research Phase I (SBIR) project will develop a new class of real time aerosol mass spectrometers (AMSs) for analysis of respirable powder and liquid aerosol in pulmonary drug delivery systems. Three parameters control the effective delivery of drugs to the lungs: (1) the number density of entrained aerosol particles per unit volume of respirable fluid; (2) the particle size distribution; (3) the concentrations of active ingredients as a function of particle size. Aerosol Mass Spectrometers, with proper calibration, can measure all three parameters simultaneously. Aerodyne Research, Inc. (ARI), in collaboration with several university research groups, has developed, demonstrated, and commercialized an innovative and quantitative AMS system. With suitable modification and calibration, this system could greatly reduce the time and effort required to characterize pulmonary drug delivery systems, both for research and for production quality assurance. This Phase I project will design and test a real-time AMS system to characterize novel pulmonary drug delivery systems.The principal commercial application of this project will be in the pulmonary drug delivery analyzer market. Potential customers are likely to include drug delivery companies, pharmaceutical companies, academic research organizations and regulatory agencies.