STTR Phase I: Porous Walled Hollow Glass Microspheres (PWHGMs): A novel sustained drug delivery platform with unique flexible capabilities

STTR 第一阶段：多孔壁空心玻璃微球（PWHGM）：一种具有独特灵活功能的新型持续给药平台

• 批准号: 2112233
• 负责人: George Wicks
• 金额: $ 25.54万
• 依托单位: SPHEROFILL, LLC
• 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: 2021-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2112233&HistoricalAwards=false
• 关键词: STTR; Phase; Porous; Walled; Hollow

The broader impact / commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop completely new technology for extended-release drugs. More than half of people told to take medicine just twice daily have trouble remembering to take both doses on time, and some drugs require dosing three- or four- times daily. This NSF project aims to create a new drug delivery system capable of programmed release over days to even weeks. The first drug product will be a treatment for malaria, which affects over 300 million people each year. Children are the most vulnerable; every 30 seconds, a child dies from malaria. Current treatments require multiple pills taken four times a day for several days. The proposed research could be transformative by enabling a cost-effective treatment taken once a day or possibly just once. The project has an enormous potential impact as the technology could create an entirely new market for drugs and drug delivery strategies impossible with current knowledge. This Small Business Technology Transfer (STTR) Phase I project focuses on a novel drug delivery platform with unprecedented capabilities. Current technology has limited ability to package and control the release of challenging drugs that are: labile, peptide- or nucleic acid-based, very hydrophilic, or very hydrophobic. The microscopic ceramic microspheres invented in the USA for national defense form the core of the technology, which is now repurposed to advance the national health and welfare. They have a thin, porous shell and a large, hollow interior that can be loaded with solids, liquids, or even gasses. The microspheres can then be sealed, and the payload released over time. This project's overall goal is to develop the drug delivery platform by focusing on a predicate proof-of-concept: achieving extended, controlled release of the anti-malarial drug Artemether over one day or longer. Challenges include developing novel ways of reliably loading and sealing the microspheres with a waxy hydrophobic drug, new methods of analyzing the product, and optimizing the drug's programmed release over time.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.

这项小型企业技术转让（STTR）第一阶段项目的更广泛影响/商业潜力是开发全新的缓释药物技术。被告知每天服药两次的人中，有一半以上的人很难记住按时服用两剂药物，有些药物需要每天服用三到四次。这个NSF项目旨在创造一种新的药物输送系统，能够在几天甚至几周内进行程序化释放。第一种药物产品将是治疗疟疾的药物，疟疾每年影响3亿多人。儿童是最脆弱的；每30秒就有一名儿童死于疟疾。目前的治疗方法需要每天服用四次，连续几天服用多种药物。拟议中的研究可能会带来变革，使每天一次或可能只需一次的经济有效的治疗成为可能。该项目具有巨大的潜在影响，因为该技术可以为现有知识无法实现的药物和药物输送策略创造一个全新的市场。这个小型企业技术转让（STTR）第一阶段项目的重点是一个具有前所未有能力的新型药物输送平台。目前的技术在包装和控制不稳定、基于肽或核酸、非常亲水或非常疏水的具有挑战性的药物释放方面的能力有限。美国为国防而发明的微型陶瓷微球构成了这项技术的核心，现在它被重新用于促进国民健康和福利。它们有一个薄而多孔的外壳和一个大而中空的内部，可以装载固体、液体甚至气体。然后，微球可以被密封起来，随着时间的推移，有效载荷就会释放出来。该项目的总体目标是通过侧重于谓词概念验证来开发药物输送平台：实现抗疟疾药物蒿甲醚在一天或更长时间内的延长、可控释放。挑战包括开发新的方法，用蜡状疏水药物可靠地装载和密封微球，分析产品的新方法，以及随着时间的推移优化药物的程序释放。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。