SBIR Phase I: Automated Analyzer for Drug Delivery Systems

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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.