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实时表征吸入器剂量的仪器，包括颗粒测量和化学分析。拟议的技术将加快吸入剂药物评价、吸入器开发、吸入器设计评价和生产级吸入器质量控制的进程。该项目的总体做法是取消采样和湿分析，而是根据含有物质特性信息的电磁发射进行化学分析。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一种使用激光诱导等离子体光谱(LIPS)来确定吸入气雾剂成分的仪器配置。所建议的配置采用整体激光衍射(ELD)技术来测量气溶胶的尺寸分布以及吸入器剂量中的颗粒物的质量。这种全光学测量将在短时间内完成剂量表征，而不需要进行劳动密集型化学分析。在第一阶段项目中，我们将使用现有的嘴唇原型，其中包括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颗粒测量组件。第一阶段项目还将包括为吸入器诊断优化的综合系统的设计。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道疾病。拟议的工作将通过更好地控制工艺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。它还将为确定吸入器剂量的特性提供一种有效的工具，从而有助于减少开发新药和吸入器设计所需的时间和成本。

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.