Novel Device to Optimize Aerosol Drug Delivery for Pulmonary Hypertension Treatment

优化肺动脉高压治疗气雾剂药物输送的新型装置

基本信息

批准号：
10698474
负责人：
John E Porterfield
金额：
$ 101.31万
依托单位：
BRIDGESOURCE MEDICAL CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10698474
关键词：
Academic Medical Centers Aerosols Affect Air Movements Area Arteries Back Blood capillaries Breathing Cessation of life Clinical Clinical Research Consult Custom Deposition Development Device Designs Devices Diagnosis Disease Disease Management Dose Drug Delivery Systems Drug Formulations Equilibrium Exhalation Formulation Goals Heart Heart failure Hour Housing Iloprost Inhalation Inhalation Therapy Interstitial Lung Diseases Lead Leadership Left Life Life Expectancy Lung Lung diseases Medial Medical Nebulizer Oral Particle Size Pathway interactions Patient Monitoring Patients Pattern Pharmaceutical Preparations Pharmacologic Substance Pharmacotherapy Pharyngeal structure Phase Physician Executives Population Population Sizes Positioning Attribute Principal Investigator Prognosis Prostaglandins Pulmonary Hypertension Radial Research Respiration Respiration Disorders Respiratory Therapy Small Business Innovation Research Grant Speed Spottings System Techniques Testing Texas Time United States Food and Drug Administration Universities aerosolized austin commercialization compliance behavior design verification effective therapy experience expiration hypertension treatment improved improved outcome invention mechanical force medication administration meter miniaturize novel older patient particle pressure pulmonary arterial hypertension respiratory sensor side effect therapeutic target tool wasting

Academic Medical Centers Aerosols Affect Air Movements Area Arteries Back Blood capillaries Breathing Cessation of life Clinical Clinical Research Consult Custom Deposition Development Device Designs Devices Diagnosis Disease Disease Management Dose Drug Delivery Systems Drug Formulations Equilibrium Exhalation Formulation Goals Heart Heart failure Hour Housing Iloprost Inhalation Inhalation Therapy Interstitial Lung Diseases Lead Leadership Left Life Life Expectancy Lung Lung diseases Medial Medical Nebulizer Oral Particle Size Pathway interactions Patient Monitoring Patients Pattern Pharmaceutical Preparations Pharmacologic Substance Pharmacotherapy Pharyngeal structure Phase Physician Executives Population Population Sizes Positioning Attribute Principal Investigator Prognosis Prostaglandins Pulmonary Hypertension Radial Research Respiration Respiration Disorders Respiratory Therapy Small Business Innovation Research Grant Speed Spottings System Techniques Testing Texas Time United States Food and Drug Administration Universities aerosolized austin commercialization compliance behavior design verification effective therapy experience expiration hypertension treatment improved improved outcome invention mechanical force medication administration meter miniaturize novel older patient particle pressure pulmonary arterial hypertension respiratory sensor side effect therapeutic target tool wasting

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项目摘要

Abstract Aerosol inhalation therapy is one of the cornerstones of respiratory therapy. The size of airborne particles determines their deposition pattern within the lungs and therefore, the efficacy of inhalation therapy. In this Phase 2 SBIR project, BridgeSource Medical (BSM) proposes to develop a breath-adaptive nebulizer with variable aerosol droplet sizes and actuation times. This can be used to administer precise doses of pharmaceutical drugs to the pulmonary system with much greater efficiency than currently available aerosol delivery devices like small-volume adaptive aerosol delivery (AAD) nebulizers that require strict patient breath timing, but do not vary droplet size. The nebulizer would be particularly beneficial in the administration of medications to treat elderly patients with respiratory conditions such as pulmonary hypertension, where long treatment times and strict requirements on patient breathing lead to poor compliance. The ultimate goal will be to develop a clinical tool that would be approved by the Food and Drug Administration (FDA) as an effective system to nebulize several drug formulations targeted for patients who cannot easily comply with strict breathing maneuvers, such as the those with advanced lung disease such as pulmonary hypertension.

抽象的气溶胶吸入疗法是呼吸疗法的基石之一。空降的大小颗粒确定其在肺部内的沉积模式，因此，吸入疗法。在此阶段2 SBIR项目中，Bridgesource Medical（BSM）提议开发具有可变气溶胶液滴尺寸和驱动时间的呼吸自适应雾化器。这可用于将精确剂量的药物用于肺系统效率比当前可用的气溶胶递送设备（如小体积）高得多需要严格呼吸时间的自适应气溶胶输送（AAD）雾化器，但不需要不同的液滴尺寸。雾化剂将对管理特别有益治疗具有呼吸系统疾病的老年患者的药物，例如肺动脉高压，较长的治疗时间和对患者呼吸的严格要求导致较差遵守。最终目标是开发一种临床工具，该工具将由食品和药物管理局（FDA）是一种有效的系统，可以扭转几种药物针对无法轻易遵守严格呼吸动作的患者的制剂，例如患有晚期肺部疾病的人，例如肺动脉高压。