SBIR/STTR Phase II: Automated Analyzer for Drug Delivery Systems

This Small Business Innovation Research Phase II project will develop a new analytical tool for characterizing drug delivery aerosols and powders. This instrument will be based on a previously developed aerosal mass spectrometer that provides real-time size distribution and chemical composition measurements for aerosol particles. During Phase I research, a new inlet for the aerosol mass spectrometer, allowing detection of particles in the size range relevant to inhalable drug delivery aerosols and powders (2 to 10 mm in diameter), was successfully developed. The key objectives of the Phase II project are : (a) to further improve the collection efficiency for particles in the 2 to 10 mm diameter size range ; (b) to design and construct a sampling apparatus that conforms to Food and Drug Administration (FDA) and U. S. Pharmacopeia Convention (USP) guidelines for sampling drug delivery aerosols from metered dose inhalers (MDIs) and dry powder inhalers (PDIs); and (c)to develop and to validate an analytical method that meets FDA standards. The commercial applications of this project will be in the area of drug delivery.