Real-time Characterization of Inhaler Doses

描述（申请人提供）：需要定期分析“吸入气雾剂给药装置”（或吸入器）释放的药物剂量。用于这种分析的常规技术涉及收集各种尺寸间隔的气溶胶并制备它们的溶液用于HPLC分析（即液相化学分析），这是劳动密集型和耗时的，并且具有高的操作成本。液相的使用使得常规布置中的分析过程复杂且缓慢。本项目旨在开发一种快速、自动化的吸入器剂量分析仪。拟议的系统将使用收集的干粉的电学/光学测量，以充分表征吸入器剂量，即确定药物质量在各种气雾剂尺寸间隔中的分布，并验证收集的药物的身份。此外，将表征结晶状态。在组合药物的情况下，所提出的分析仪将量化组分药物的比例。所提出的技术还将能够分析通过吸入器的单次驱动释放的药物（如FDA关于吸入器剂量分析的指南所推荐的），而不是常规方法通常需要的多次驱动。该项目汇集了一家小型高科技企业、一家大型制药公司、一家中型制药仪器公司和一所大学实验室的资源。将为吸入器剂量分析制造基于新的创新方法的原型仪器，并在工业研发和生产环境中进行广泛测试。在SBIR第二阶段项目完成后不久，基于拟议技术的两种产品将投入商业使用。这些产品在2020年的市场规模估计为2800万美元/年，每年至少增长5%。拟议的工作将有助于改善人民的健康，支持呼吸系统疾病的治疗，并可能在未来的肺癌。所提议的仪器的可用性将能够增强吸入药物递送装置的安全性和有效性。公共卫生相关性：SBIR第二阶段项目涉及吸入器剂量的分析。所提出的方法分析粉末形式的吸入器剂量，并有望用于高速和全自动测量。在这个项目结束时，我们希望在工业研发和制造环境中建立和测试原型。

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.