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.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力将通过非侵入性鼻腔给药改善患者的预后。鼻腔是一种非侵入性药物输送管道，作用迅速且价格低廉。局部鼻内药物治疗鼻窦，神经系统和全身性疾病。拟议的创新将显着改善鼻腔药物输送和患者的结果，使药物确切地在需要去的地方。这将是第一个小型化的雾化技术，并可广泛应用于其他领域。最初设想的应用是慢性鼻窦炎，影响10%的人口，每年花费美国医疗保健120亿美元。这个小企业创新研究（SBIR）第一阶段项目推进了一种新的鼻腔给药系统。 目前的局部药物递送具有有限的有效性，因为它们依赖于通过复杂的鼻解剖结构的远距离颗粒雾化。为了克服这一点，将开发一种将药物直接递送到解剖目标的自施用的基于导管的雾化药物递送装置。然而，雾化仅存在于较大的刚性形状因子中。本研究的目的是开发一种新型雾化器，保持一个小，灵活的形状因素纳入导管头端。像这样的新系统对于有效的、可耐受的鼻腔给药至关重要。将进行计算流体动力学模拟，以确定原型设计和施工。设计将通过微成型，挤出操作和微3D打印的包覆成型来制造。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，喷雾角度，速度和羽流几何形状）和解剖模型，以评估流体沉积。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。