Real-time Characterization of Inhaler Doses

吸入器剂量的实时表征

基本信息

批准号：
7769521
负责人：
AMIR A NAQWI
金额：
$ 38.13万
依托单位：
POWERSCOPE, INC
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-07-01 至 2012-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7769521
关键词：
Aerosols Agreement Animals Area Asthma Automation Beclomethasone Dipropionate Biological Assay Biological Availability Breathing Businesses Calibration Capital Carbon Charge Chemical Structure Chemicals Chromatography Collection Complex Computer software Computers Consult Deposition Development Device or Instrument Development Devices Dose Drops Drug Combinations Drug Delivery Systems Electronics Engineering Ensure Environment Equilibrium Equipment Ethanol Excipients Funding Future Gases Goals Hand Health Health Sciences High Pressure Liquid Chromatography Hour In Situ Individual Inhalators Insulin Intervention Investments Ions Knowledge Laboratories Laboratory Technicians Lactose Lasers Lead Liquid substance Location Lung Lung diseases Malignant neoplasm of lung Manufacturer Name Marketing Masks Measurement Measures Metered Dose Inhaler Device Methods Microscope Minor Modification Nebulizer Nose Oleic Acids Optics Ozone Particle Size Patients Performance Pharmaceutical Preparations Pharmacologic Substance Phase Powder dose form Preparation Procedures Process Production Psychotic Disorders Qualifying Quality Control Raman Spectrum Analysis Research Research Design Resources Safety Sample Size Sampling Scientific Advances and Accomplishments Scientist Small Business Innovation Research Grant Solid Solutions Solvents Speed Spottings Staging Structure System Techniques Technology Testing Therapeutic Agents Time Training Universities Vacuum Pumps Variant Work aerosolized analytical method base commercialization comparative cost drug discovery drug inhalation grasp improved innovation instrument instrumentation ionization light scattering neutrophil non-drug particle pressure programs propellant prototype public health relevance ratiometric research and development skills software development voltage

项目摘要

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.

描述（由申请人提供）：需要定期分析“吸入气溶胶输送设备”（或吸入器）发布的药物剂量。用于此类分析的常规技术涉及以各种尺寸间隔收集气溶胶，并准备其解决方案进行HPLC分析（即液相化学分析），这是劳动力密集且耗时且运营成本高的。液相的使用使分析过程复杂而常规排列的缓慢。该项目旨在为吸入剂量开发快速自动化的分析仪。所提出的系统将使用收集的干粉的电/光学测量值，以完全表征吸入器剂量，即确定在各种气溶胶尺寸间隔中确定药物质量的分布，并验证收集的药物的身份。此外，将表征结晶度。在联合药物的情况下，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吸入器的单个致动物（根据FDA的吸入剂量分析指南的首选），而不是常规方法通常需要多种驱动。该项目将一家小型高科技业务的资源与一家大型制药公司，一家中型制药仪器公司和大学实验室汇集在一起。基于新的和创新方法的原型仪器将用于吸入器剂量分析，并在工业研发和生产环境中进行了广泛的测试。该SBIR II期项目完成后不久，基于提议的技术的两种产品应在商业上获得。这些产品在2020年的市场规模估计为每年2800万美元，每年至少增长5％。拟议的工作将通过支持呼吸系统疾病的治疗以及将来的肺癌来帮助改善人们的健康。提议的仪器的可用性将使吸入药物输送设备的安全性和功效增强。公共卫生相关性：该SBIR II期项目涉及吸入剂量的分析。所提出的方法以粉末的形式分析吸入剂剂量，并且有望用于高速和完全自动化的测量。到该项目结束时，我们希望在工业研发和制造环境中建立和测试原型。