Real-time Characterization of Inhaler Doses

描述（由申请人提供）：这项工作的长期目标是开发一种用于吸入器剂量实时表征的仪器，包括颗粒大小和化学分析。该技术将加速吸入药物评价、吸入器开发、吸入器设计评价和生产级吸入器质量控制的过程。这个项目的总体方法是取消采样和湿分析，取而代之的是在电磁发射的基础上进行化学分析，其中包含有关物质身份的信息。随着激光和光电子学的进步，这种方法变得可行。本项目的具体目的是评估使用激光诱导等离子体光谱（LIPS）确定吸入气溶胶成分的特定仪器配置。所提出的配置采用集合激光衍射（ELD）技术来测量气溶胶大小分布以及吸入器剂量中颗粒物的质量。这种全光学测量可以在短时间内完成剂量表征，而无需进行劳动密集型的化学分析。在第一期项目中，我们将使用现有的LIPS原型与选定的吸入药物和其他吸入剂量成分，以确定该技术的可行性。此外，现有的ELD系统将用于评估拟议仪器的粒度组成部分。第一阶段项目还将包括设计一个优化吸入器诊断的综合系统。这项工作涉及公共卫生关注的一个主要领域，即影响数百万人的呼吸系统疾病。拟议的工作将通过提供更好的工艺控制来支持吸入器的制造，从而降低制造成本并提高吸入器的质量。它还将通过提供表征吸入器剂量的有效工具，帮助减少开发新药和设计吸入器所涉及的时间和成本。

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.