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发炎，导致呼吸和呼吸急促的攻击。美国约有5％的人口患有哮喘，这种疾病的患病率不断增加。向患者提供哮喘药物的最常见方法是计量剂量吸入器（MDIS）。由于CFC的臭氧消耗效果，使用氯氟化合物（CFC）的传统MDI很快就会被淘汰；正在开发一类新的推进剂来替代CFC。但是，由于（1）协调致动和灵感的难度，（2）产生的气溶胶的粒径不足以递送到治疗上重要的小支气管菌，以及（3）制剂的难度。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明显的缺点。它们包括剂量不稳定性，不一致的排放剂量和次优的气溶胶粒径。所有当前的吸入输送系统都包含大量的赋形剂；肺输送中的赋形剂可能引起气道超敏反应。因此，对于当前递送系统的环保替代品非常需要，该替代品能够生成适合药物递送到小支气管的尺寸且配方中没有赋形剂的气溶胶颗粒。 Alexza MDC开发了一种新型技术来产生高纯度的药物气溶胶。哮喘药物输送的设想吸入装置将被呼吸，并具有适当的颗粒尺寸的气溶胶，以递送到没有赋形剂的小气道。赠款第一阶段的目标是证明构建这样的设备的可行性，该设备提供了使用该技术的通用支气管扩张剂（一种常见的支气管扩张剂），使用该技术具有较高的纯度和适当的粒径，可用于哮喘治疗。成功完成活动的活动将迈出重要的一步，以开发改进的吸入药物输送平台进行哮喘治疗。