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

这个小型企业技术转让(STTR)第一阶段项目的更广泛的影响/商业潜力是为缓释药物开发全新的技术。被告知每天只吃两次药的人中，超过一半的人记不住按时服用两剂药，有些药物需要每天服用三到四次。NSF的这个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程序化释放。第一个药物产品将用于治疗疟疾，每年有超过3亿人受到疟疾的影响。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连续几天每天服用四次多次药片。拟议中的研究可能具有变革性，能够实现一天一次或可能只进行一次的具有成本效益的治疗。该项目具有巨大的潜在影响，因为该技术可能为药物和药物输送策略创造一个全新的市场，而目前的知识是不可能的。这个小型企业技术转让(STTR)第一阶段项目专注于一种具有前所未有能力的新型药物输送平台。目前的技术对包装和控制具有挑战性的药物的释放的能力有限，这些药物是：不稳定的、基于多肽或核酸的、非常亲水的或非常疏水的。美国为国防发明的微型陶瓷微球构成了这项技术的核心，现在这项技术被重新用于促进国民健康和福利。它们有一个薄薄的多孔外壳和一个巨大的中空内部，可以装载固体、液体甚至气体。然后可以密封微球，并随着时间的推移释放有效载荷。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传递平台：实现抗疟疾药物蒿甲醚在一天或更长时间内的延长、受控释放。挑战包括开发用蜡质疏水药物可靠地加载和密封微球的新方法，分析产品的新方法，以及随着时间的推移优化药物的程序化释放。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.