Real-time Characterization of Inhaler Doses

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DESCRIPTION (provided by applicant): The long-term objective of this work is to develop an instrument for real-time characterization of inhaler doses, covering particle sizing and chemical analysis. The proposed technique would accelerate the processes of inhalation drug evaluation, inhaler development, inhaler design evaluation and production-level inhaler quality control. The overall approach in this project is to eliminate sampling and wet analysis and instead, perform chemical analysis on the basis of electromagnetic emissions that contain information about the identity of substances. This approach is becoming feasible with the advances in lasers and optoelectronics. The specific aim of the present project is to evaluate a certain instrument configuration that uses Laser Induced Plasma Spectroscopy (LIPS) for determining the composition of inhalation aerosols. The proposed configuration employs Ensemble Laser Diffraction (ELD) technique for the measurement of aerosol size distribution as well as mass of the particulate matter in an inhaler dose. This all optical measurement would enable complete dose characterization in a short time without labor-intensive chemical analysis. In the Phase I project, we will use an existing prototype of LIPS with selected inhalation drugs and other inhalation dose components in order to determine the feasibility of the technique. Also, an existing ELD system will be used to evaluate the particle sizing component of the proposed instrument. Phase I project will also cover the design of an integrated system optimized for inhaler diagnostics. This work addresses a major area of public health concern, i.e. respiratory diseases, which affect millions of people. Proposed work will support manufacturing of inhalers by providing a better control of the process, thereby reducing manufacturing costs and improving the quality of inhalers. It will also help reduce the time and cost involved in the development of new drugs and inhaler designs by providing an efficient tool for the characterization of inhaler doses.