AIR Option 1: Technology Translation - Proof-of-concept testing and technology translation for engineered nanocomposites

AIR 选项 1：技术翻译 - 工程纳米复合材料的概念验证测试和技术翻译

• 批准号: 1312125
• 负责人: Rajesh Dave
• 金额: $ 15万
• 依托单位: New Jersey Institute of Technology
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2015-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1312125&HistoricalAwards=false
• 关键词: AIR; Option; Technology; Translation; Proof

This PFI: AIR Technology Translation project focuses on translating innovative surface modification science with fluid-bed coating technology for producing fine drug nano-composite particles to fill current technology gap of lack of scalable and economically feasible methods to produce highly bioavailable drug composite particles that do not have a gritty mouth-feel, which is undesirable for patients with swallowing disorders. The translated science-based technology has the following unique features: very fast dissolution even for poorly water soluble drugs, a size small enough for incorporation into orally disintegrating dosages, and excellent flow and handing properties that provide exemplary performance using conventional robust processing methods that lead to efficient, scalable and cost-effective manufacturing when compared to the leading competing technologies such as spray drying and hot-melt extrusion for bioavailability enhancement, or freeze-dried fast disintegrating dosage forms in this market space. The project accomplishes this goal by combining fundamental aspects of surface science to reduce cohesion of carrier particles and to stabilize nano-drug particles, which are 300 times smaller than the diameter of human hair, to preserve their large surface area resulting in a proof-of-concept highly bioavailable drug composite particle that is taste-masked, and is less than 50 microns, i.e., smaller than the diameter of human hair. The partnership engages Catalent Pharma Solutions, a contract manufacturer, along with their pharmaceutical company clients to provide guidance in the technological as well as regulatory aspects of orally disintegrating dosage forms and other aspects such as patentability, market research, financing, and commercialization as they pertain to the potential to translate the science based technology along a path that may result in a competitive commercial reality. The final output of the commercialization is a robust manufacturing platform that is applicable to any poorly water soluble drug and forming fast dissolving drug-composite small particles that can be used in chewable tablets, syrups, strip-films or lozenges, targeting patients having swallowing disorders, thus increasing patient compliance. As a reference, the majority of newly discovered drugs are almost insoluble in water; while the market for dysphagia alone is currently over $3B/year. The potential economic impact is expected to be well over $100M/year in the next five to fifteen years, which will contribute to the U.S. competitiveness in the pharmaceutical sector, since nanostructured particulates are produced via methods that have scalability, reproducibility, low cost, and high-yield, and the products will have better bioavailability, are smaller and are essential components of next generation pharmaceutical manufacturing. Similarly, it can have an impact on other industries; such as; food, agrochemical, nutrient delivery, cosmetics, as well as dental and bio-materials. The societal impact, long term, will be in robust manufacturing platform that leads to products that provide improved patient comfort, hence compliance, and improved performance using simple, cost-effective processes, as well as have the reduced-risk of using nano-particles through lack of associated exposure to factory workers.

该 PFI：AIR 技术翻译项目侧重于将创新的表面改性科学与流化床包衣技术转化为生产精细药物纳米复合颗粒，以填补目前缺乏可扩展且经济可行的方法来生产高生物利用度药物复合颗粒的技术空白。没有粗糙的口感，这对于吞咽障碍患者来说是不受欢迎的。 这种基于科学的技术具有以下独特的特点：即使对于水溶性差的药物也能非常快速地溶解，尺寸小到足以掺入口腔崩解剂型中，以及优异的流动和处理性能，使用传统的稳健加工方法提供了示范性的性能，与该市场领域的领先竞争技术（例如用于增强生物利用度的喷雾干燥和热熔挤出或冻干快速崩解剂型）相比，可实现高效、可扩展和经济高效的制造。 该项目通过结合表面科学的基本方面来实现这一目标，以减少载体颗粒的内聚力并稳定比人类头发直径小 300 倍的纳米药物颗粒，以保留其大表面积，从而证明了-概念性高生物利用度药物复合颗粒，其味道被掩盖，并且小于50微米，即小于人头发的直径。该合作伙伴关系让合同制造商 Catalent Pharma Solutions 及其制药公司客户在口腔崩解剂型的技术和监管方面以及相关的专利性、市场研究、融资和商业化等其他方面提供指导沿着可能导致竞争性商业现实的道路转化基于科学的技术的潜力。 商业化的最终成果是一个强大的制造平台，适用于任何水溶性差的药物，并形成快速溶解的药物复合小颗粒，可用于咀嚼片、糖浆、条膜或含片，针对吞咽障碍患者，从而提高患者的依从性。作为参考，大多数新发现的药物几乎不溶于水；而仅吞咽困难的市场目前就超过 3B 美元/年。预计未来五到十五年潜在的经济影响将远远超过每年 1 亿美元，这将有助于提高美国在制药行业的竞争力，因为纳米结构颗粒是通过具有可扩展性、可重复性、低成本、产量高，产品具有更好的生物利用度，体积更小，是下一代制药生产的重要组成部分。 同样，它也会对其他行业产生影响；例如;食品、农用化学品、营养输送、化妆品以及牙科和生物材料。 从长远来看，社会影响将体现在强大的制造平台上，该平台生产的产品可以提高患者舒适度，从而提高合规性，并使用简单、经济高效的工艺提高性能，并降低使用纳米颗粒的风险由于缺乏与工厂工人的相关接触。