SBIR Phase I: Development of a Novel Miniature Spray Mechanism for Nasal Drug Delivery

SBIR 第一阶段：开发用于鼻腔给药的新型微型喷雾机制

• 批准号: 2136461
• 负责人: Adam Gold
• 金额: $ 25.6万
• 依托单位: NASUS MEDICAL INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2136461&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Novel; Miniature

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will improve patient outcomes through non-invasive nasal drug delivery. The nasal cavity is a non-invasive drug delivery conduit that is rapid-acting and inexpensive. Topical intranasal medications treat sinus-nasal, neurologic, and systemic diseases. The proposed innovation will significantly improve nasal drug delivery and patient outcomes by getting medication exactly where it needs to go. It will be the first miniaturized atomization technology and can be broadly applied to other fields. The initial envisioned application is chronic sinusitis, which affects 10% of the population and costs US healthcare $12 billion/year. This Small Business Innovation Research (SBIR) Phase I project advances a new nasal drug delivery system. Current topical drug deliveries have limited effectiveness because they rely on distant particle atomization through complex nasal anatomy. To overcome this, a self-administered, catheter-based atomization drug delivery device that delivers drug directly to the anatomic target will be developed. However, atomization only exists in larger, rigid form factors. The objective of this research is to develop an novel atomizer that maintains a small, flexible form factor to be incorporated into the catheter tip. A new system like this is crucial for effective, tolerable nasal drug delivery. Computational Fluid Dynamics simulations will be performed to determine prototype design and construction. Designs will be manufactured through micromolding, extrusion manipulation, and overmolding with micro-3D printing. Designs will be tested using laser diffraction to evaluate spray characteristics (droplet size distribution, spray angle, velocity, and plume geometry) and anatomic models to evaluate fluid deposition.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）I阶段项目的更广泛的影响/商业潜力将通过非侵入性鼻药提供改善患者的结果。鼻腔是一种非侵入性药物输送导管，速度快速且廉价。局部鼻内药物治疗鼻窦，神经系统疾病和全身性疾病。拟议的创新将通过将药物准确地去哪里来大大改善鼻药的递送和患者预后。这将是第一个微型雾化技术，可以广泛应用于其他领域。最初的设想应用是慢性鼻窦炎，它影响了10％的人口，耗资美国医疗保健120亿美元。这项小型企业创新研究（SBIR）I阶段项目推动了一种新的鼻药输送系统。 当前的局部药物递送的有效性有限，因为它们通过复杂的鼻腔解剖依赖远处的颗粒雾化。为了克服这一点，将开发出一种自我管理的，基于导管的基于导管的雾化药物输送装置，直接将药物运送到解剖靶标。但是，雾化仅存在于较大的刚性形式。这项研究的目的是开发一种新型的雾化器，该雾化器维持一个小而柔软的外形，以纳入导管尖端。这样的新系统对于有效，可耐受的鼻药递送至关重要。将进行计算流体动力学模拟，以确定原型设计和构造。设计将通过微块，挤压操作和微型3D打印来制造。设计将使用激光衍射进行测试，以评估喷雾特性（液滴尺寸分布，喷雾角，速度和羽状几何形状）和解剖模型，以评估流体沉积。该奖项反映了NSF的法定任务，并被认为是通过基金会的知识功能和广泛影响的评估来评估NSF的法定任务。