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

本PFI: AIR技术翻译项目致力于将创新的表面修饰科学转化为流化床涂层技术，用于生产精细的药物纳米复合颗粒，以填补目前缺乏可扩展和经济可行的方法来生产高生物利用度的药物复合颗粒的技术空白，这些药物复合颗粒不具有吞咽障碍患者所不希望的砂粒口感。翻译后的科技具有以下特点：即使对水溶性差的药物也能快速溶解，尺寸小到足以纳入口服崩解剂量，与喷雾干燥和热熔挤压等领先的竞争技术相比，使用传统稳健的加工方法提供了卓越的流动性和处理性能，从而实现高效、可扩展和成本效益高的生产。或冻干快速崩解剂型在这个市场空间。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纳米药物颗粒，纳米药物颗粒比人类头发直径小300倍，以保持其大表面积，从而产生一种具有高度生物利用度的概念验证药物复合颗粒，这种颗粒可以掩盖味道，小于50微米，即小于人类头发的直径。该合作伙伴关系涉及合同制造商Catalent Pharma Solutions及其制药公司客户，为口腔崩解剂型的技术和监管方面以及可专利性、市场研究、融资和商业化等其他方面提供指导，因为它们涉及将基于科学的技术转化为可能导致竞争性商业现实的路径的潜力。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，可用于咀嚼片剂、糖浆、带状膜或含片，针对患有吞咽障碍的患者，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每年就超过30亿美元。在未来5到15年，潜在的经济影响预计将超过1亿美元/年，这将有助于美国在制药领域的竞争力，因为纳米结构颗粒的生产方法具有可扩展性，可重复性，低成本和高产量，产品将具有更好的生物利用度，体积更小，是下一代制药制造的重要组成部分。同样，它也会对其他行业产生影响；等;食品，农化，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，这将导致产品提供更好的患者舒适度，从而提高依从性，并使用简单，具有成本效益的工艺提高性能，以及通过减少与工厂工人的相关接触而降低使用纳米颗粒的风险。

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.