Asthma Treatment with a Novel Drug Aerosol Generator

使用新型药物气雾发生器治疗哮喘

• 批准号: 6789671
• 负责人: WILLIAM W SHEN
• 金额: $ 20.1万
• 依托单位: ALEXZA MOLECULAR DELIVERY CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-20 至 2005-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6789671
• 关键词: aerosols; albuterol; asthma; bioengineering /biomedical engineering; biomedical equipment development; chemical stability; clinical biomedical equipment; dosage forms; drug administration rate /duration; drug delivery systems; drug preservation; evaluation /testing; gas chromatography mass spectrometry; high performance liquid chromatography; humidity; inhalation drug administration; liquid chromatography mass spectrometry; patient safety /medical error; portable biomedical equipment; respiratory disorder chemotherapy; ultraviolet spectrometry

DESCRIPTION (provided by applicant): Asthma is a chronic disease characterized by inflammation of the airways and lung, causing attacks characterized by wheezing and shortness of breath. Around 5% of the population in the United States suffers from asthma, with the prevalence of this disease continuing to rise. The most common method to deliver asthma medications to patients is metered dose inhalers (MDIs). Traditional MDIs using chlorofluorocarbons (CFCs) will soon be phased out due to CFCs' ozone-depleting effect; a new class of propellants is being developed to replace CFCs. However, MDIs in general are not optimal for asthma treatment because of (1) the difficulty in coordinating actuation and inspiration, (2) excessively large particle size of generated aerosols inadequate for delivery to therapeutically important small bronchioles, and (3) difficulty in formulation. Other inhalation delivery platforms, such as dry powder inhalers and nebulizers, also have significant disadvantages in treating asthma; they include dose form instability, inconsistent emitted dose, and suboptimal aerosol particle size. All current inhalation delivery systems contain significant amounts of excipients; excipients in pulmonary delivery may induce airway hypersensitivity. Thus, there is a substantial need for an environmentally friendly alternative to current delivery systems that is able to generate aerosol particles with sizes suitable for drug delivery to small bronchioles and without excipients in the formulation. Alexza MDC has developed a novel technology to generate drug aerosol of high purity. The envisioned inhalation device for asthma drug delivery will be breath actuated and aerosols with appropriate particle sizes for delivery to small airways free of excipients. The goal in Phase I of the grant is to demonstrate the feasibility of building such a device that delivers albuterol, a common bronchodilator, with high purity and appropriate particle size for asthma treatment using this technology. Successful completion of activities in Phase I would present a significant step towards developing an improved inhalation drug delivery platform for asthma treatment.

描述（由申请人提供）：哮喘是一种慢性疾病，其特征是气道和肺部炎症，导致以喘息和呼吸短促为特征的发作。美国约有 5% 的人口患有哮喘，而且这种疾病的患病率持续上升。向患者提供哮喘药物的最常见方法是定量吸入器 (MDI)。由于CFCs的臭氧消耗效应，使用氯氟烃（CFCs）的传统计量吸入器很快将被淘汰；正在开发一类新型推进剂来替代氟氯化碳。然而，MDI 通常不是哮喘治疗的最佳选择，因为 (1) 难以协调驱动和吸气，(2) 产生的气雾剂粒径过大，不足以输送到具有治疗意义的小细支气管，以及 (3) 配制困难。其他吸入输送平台，例如干粉吸入器和雾化器，在治疗哮喘方面也有显着的缺点；它们包括剂型不稳定、发射剂量不一致以及气溶胶粒径不理想。目前所有的吸入给药系统都含有大量的赋形剂；肺部输送中的赋形剂可能引起气道过敏。因此，迫切需要一种环境友好的替代方案来替代当前的递送系统，该系统能够产生尺寸适合将药物递送至小细支气管的气雾剂颗粒，并且制剂中无需赋形剂。 Alexza MDC 开发了一种新技术来生成高纯度药物气雾剂。设想的用于哮喘药物输送的吸入装置将是呼吸驱动的，并且气雾剂具有适当的颗粒尺寸，用于输送至小气道且不含赋形剂。第一阶段拨款的目标是证明建造这样一种设备的可行性，该设备可提供沙丁胺醇（一种常见的支气管扩张剂），具有高纯度和适当的粒径，用于使用该技术治疗哮喘。第一阶段活动的成功完成将为开发改进的哮喘治疗吸入药物输送平台迈出重要一步。