SBIR Phase I: The novel NanoCont drug delivery technology for creating nanoformulated medicines with improved safety, better quality, and more predictable clinical responses.

这个SBIR第一阶段项目正在为制药公司开发一种新的药物输送技术，这些公司拥有的药物产品或研究化合物表现出较差的水溶性和较低的生物利用度。NanoContTM技术将为FDA批准的和正在研究的化合物创造新的纳米配方药物产品提供一种快速和具有成本效益的方法。从商业化的角度来看，这项技术将：(1)创造FDA批准的化合物的改进纳米制剂，以延长现有药物的专利寿命和市场排他性，从而为制药公司提供实质性价值；(2)纳米制剂研究化合物，以提高它们的溶出度和生物利用度，并促进原本可能被放弃的有前景的候选药物的开发；(3)在持续制造平台上进行开发，这将降低总体开发成本，缩短交货期，减少制造足迹，并允许制造活动(目前外包到国外)迁回美国。因此，预计NanoContTM将对制药公司产生很大的商业影响，促进新型候选药物的开发，使患者受益，并通过提高美国的制造效率和制造就业机会提供经济价值。MAA实验室(MAA)正在为具有较差水溶性和低生物利用度的药物产品或研究化合物的制药公司开发一种新型药物输送技术。NanoContTM药物输送技术是一种制造平台，它使用受专利保护的产品特定配方和工艺条件来创造纳米晶体，并通过专利的聚合物包衣工艺来覆盖和稳定纳米晶体。药物纳米粒的聚合物包衣起到了防止团聚的能量屏障的作用，从而保持了增强的溶出特性和产品的长期稳定性，并防止了下游问题，如生物利用度和/或剂量不一致。NanoContTM平台预计将是一项颠覆性技术，因为它提供了严格控制的颗粒大小/尺寸分布、颗粒稳定性、低成本可扩展性以及在连续制造平台上的实施。没有具有竞争力的产品能够提供这种独特的好处组合。综上所述，MAA？S纳米ContTM给药技术为在由药学上可接受的聚合物制成的聚合物包衣结构中纳米形成药物晶体提供了一种新的方法。在连续制造平台上提出的技术有望提供一种快速、容易扩展和广泛适用的过程，用于开发和传递难溶化合物作为具有良好溶出度、安全性和PK特性的新型可专利药物产品。

This SBIR Phase I project is developing a novel drug delivery technology for pharmaceutical companies with drug products or investigational compounds that exhibit poor aqueous solubility and low bioavailability. NanoContTM technology will provide a rapid and cost-effective approach for creating novel nanoformulated drug products for FDA-approved and investigational compounds. From a commercialization perspective, the technology will: (1) create improved nanoformulations of FDA-approved compounds to extend patent life and market exclusivity of established drugs, thus providing substantial value to pharmaceutical companies; (2) nanoformulate investigational compounds to increase their dissolution rate and bioavailability and facilitate the development of promising drug candidates that would otherwise be abandoned; (3) be developed on a continuous manufacturing platform, which will reduce overall development costs, decrease lead time, decrease manufacturing footprint, and permit manufacturing activities (currently outsourced abroad) to be relocated back to the U.S. Therefore, the NanoContTM is expected to have high commercial impact for pharmaceutical companies, facilitate development of novel drug candidates to benefit patients, and provide economic value by increasing manufacturing efficiencies and manufacturing jobs in the U.S. MAA Laboratories (MAA) is developing a novel drug delivery technology for pharmaceutical companies with drug products or investigational compounds that exhibit poor aqueous solubility and low bioavailability. The NanoContTM drug delivery technology is a manufacturing platform that uses patent protected product specific formulation and process conditions to create nanocrystals and a patented polymer-coating process to coat and stabilize the nanocrystals. Polymer-coating of the drug nanoparticles acts as an energy barrier to prevent agglomeration, thus maintaining the enhanced dissolution characteristics and long-term product stability, as well as preventing downstream problems, such as inconsistent bioavailability and/or dosing. The NanoContTM platform is expected to be a disruptive technology because it offers strictly controlled particle size/size distribution, particle stabilization, low-cost scalability, and implementation on a continuous manufacturing platform. There are no competitive products that offer this unique combination of benefits. In summary, MAA?s NanoContTM drug delivery technology provides a novel method for nanoformulating pharmaceutical crystals in a polymer coated structure made of pharmaceutically acceptable polymers. The proposed technology on a continuous manufacturing platform is expected to provide a rapid, readily scalable, and broadly applicable process for developing and delivering poorly soluble compounds as novel patentable drug products with favorable dissolution, safety, and PK characteristics.