Real-time Characterization of Inhaler Doses

吸入器剂量的实时表征

• 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
• 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

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）：通过“吸入气溶胶输送装置”（或吸入器）释放的药物剂量需要定期分析。这种分析的传统技术是收集不同大小间隔的气溶胶，并制备其溶液进行HPLC分析（即液相化学分析），这是一种劳动密集、耗时且运行成本高的技术。液相的使用使传统的分析过程复杂而缓慢。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/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溶胶大小间隔中的分布，并验证收集的药物的身份。此外，结晶状态将被表征。在联合药物的情况下，所提出的分析仪将量化所述组分药物的比率。拟议的技术还可以分析吸入器的单次驱动所释放的药物（这是FDA对吸入器剂量分析指南的首选），而不是传统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与一家大型制药公司、一家中型制药仪器公司和一所大学实验室的资源。将建立基于新的创新方法的原型仪器，用于吸入器剂量分析，并在工业研发和生产环境中进行广泛测试。在SBIR第二期项目完成后不久，基于拟议技术的两种产品将投入商业使用。到2020年，这些产品的市场规模预计将达到2800万美元/年，并将以每年至少5%的速度增长。拟议的工作将有助于改善人们的健康，支持呼吸系统疾病的治疗，未来可能还有肺癌的治疗。拟议仪器的可用性将提高吸入给药装置的安全性和有效性。公共卫生相关性：SBIR第二期项目涉及吸入器剂量的分析。提出的方法以粉末形式分析吸入器剂量，有望实现高速和全自动测量。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原型并进行测试。