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.

这项PFI：空气技术翻译项目致力于使用流体床涂层技术翻译创新的表面修饰科学，以生产精细的药物纳米复合颗粒，以填补缺乏可扩展性和经济性可行的方法来产生高度可生物利用的药物复合颗粒，这些方法对swallisors a and swallite swallite swallite swallipsants a venteriose的不足是不可或缺的。 翻译的基于科学的技术具有以下独特功能：即使对于水溶性糟糕的药物，也非常快速解散，足够小的尺寸足以掺入口服口服瓦解剂量中，以及出色的流量和交手特性，可提供常规的鲁棒加工方法，可通过常规的鲁棒加工方法提供高效，可伸缩和易于竞争性的技术，例如，与领先的技术相比，既可以脱颖而出，又可以进行竞争性的技术，并具有竞争力的技术，并具有竞争力的技术，并具有竞争力的斗争，并具有竞争力的斗争，并具有竞争性的斗争性，并具有良好的技术性，并与竞争性的技术进行了斗争，并具有良好的效果。在这个市场空间中，冷冻干燥的快速分解剂型。 该项目通过结合表面科学的基本方面来减少载体颗粒的凝聚力并稳定纳米毒物颗粒的凝聚力，从而实现这一目标，稳定纳米毒物颗粒（比人头发直径小的300倍，以保持其较大的表面区域，从而使概念证明具有高度生物可生物可利用的可生物可利用的药物复合粒子，而毛发却比人远不止于50微米。合同制造商的合作伙伴关系与其制药公司客户融合了Catalent Pharma Solutions，以在口头瓦解剂型的技术和法规方面提供指导，并提供可取剂型的形式以及其他方面的可爱性，市场研究，融资，融资和商业化，因为它们可能会涉及基于科学的技术，而这些技术可能会导致一项竞争性的实现竞争性的竞争性，并可能将基于科学的技术转化。 商业化的最终输出是一个可靠的制造平台，适用于任何水溶性差的药物，并形成可以用于咀嚼片，糖浆，带状膜或小lo的快速溶解药物复合小颗粒，针对患有吞咽疾病的患者，从而提高患者依从性。作为参考，大多数新发现的药物几乎不溶于水。虽然仅吞咽困难的市场目前超过$ 3B/年。预计在未来五到15年内，潜在的经济影响预计将超过1亿美元/年，这将有助于美国在药品领域的竞争力，因为纳米结构的微粒是通过具有可扩展性，可延展性，低成本，低成本和高产的方法来生产的，并且产品将具有更好的生物学能力，因此具有较小的生产力。 同样，它可能会对其他行业产生影响。例如;食物，农业化学，营养递送，化妆品以及牙齿和生物材料。 长期的社会影响将是在强大的制造平台中，从而导致产品可改善患者舒适度，因此使用简单，经济高效的过程，以及通过缺乏与工厂工人相关的相关风险，使用纳米粒子的降低风险。