Real-time Characterization of Inhaler Doses

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DESCRIPTION (provided by applicant): Drug doses released by 'inhalation aerosol delivery devices' (or inhalers) need to be analyzed regularly. The conventional technology for such analysis involves collection of aerosols in various size intervals and preparation of their solutions for HPLC analysis (i.e. liquid-phase chemical analysis), which is labor intensive and time consuming and has a high operating cost. The use of liquid phase makes the analytical process complex and slow in the conventional arrangement. This project aims at developing a fast and automated analyzer for inhaler doses. The proposed system will use electrical/optical measurements of the collected dry powder, in order to fully characterize inhaler doses, i.e. determine distribution of the mass of drug in various aerosol size intervals, and validate the identity of the collected drug. Further, state of crystallinity will be characterized. In the case of a combination drug, the proposed analyzer will quantify ratio of the component drugs. The proposed technique would also enable analysis of the drug released by a single actuation of an inhaler (as preferred by FDA Guidance on analysis of inhaler doses), as opposed to multiple actuations often needed with the conventional approach. This project brings together the resources of a small high-tech business with a major pharmaceutical company, a medium-size pharmaceutical instrumentation company and a university laboratory. Prototype instruments based on the new and innovative approaches will be built for inhaler dose analysis and tested extensively in industrial R&D and production environments. Shortly after completion of this SBIR Phase II project, two products based on the proposed technologies should become commercially available. Market size for these products in 2020 is estimated to be $28M/year and would be growing at least 5% annually. The proposed work would help improve the health of the people by supporting the treatment of respiratory diseases, and possibly lung cancer in the future. Availability of the proposed instrumentation would enable enhanced safety and efficacy of inhalation drug delivery devices. PUBLIC HEALTH RELEVANCE: This SBIR Phase II project deals with the analysis of inhaler doses. The proposed approach analyzes the inhaler doses in the form of powder and is promising for high-speed and fully automated measurements. By the end of this project, we expect to have prototypes built and tested in the industrial R&D and manufacturing environments.