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

该SBIR I期项目正在为制药公司开发一种新型药物递送技术，其药物产品或研究化合物表现出水溶性差和生物利用度低。NanoContTM技术将提供一种快速和具有成本效益的方法，用于为FDA批准的和研究性化合物创建新型纳米制剂。从商业化的角度来看，该技术将：（1）创建FDA批准的化合物的改进纳米制剂，以延长专利寿命和已建立药物的市场独占性，从而为制药公司提供实质性价值;（2）纳米制剂研究化合物，以提高其溶解速率和生物利用度，并促进开发有前途的候选药物，否则将被放弃;（3）在一个连续的制造平台上开发，这将降低总体开发成本，缩短交货时间，减少制造占地面积，并允许制造活动因此，NanoContTM预计将对制药公司产生很大的商业影响，促进新药候选药物的开发，使患者受益，并通过增加美国的制造效率和制造工作来提供经济价值。MAA实验室（MAA）正在为制药公司开发一种新的药物递送技术，该技术具有表现出差的水溶性和低生物利用度的药物产品或研究化合物。NanoContTM药物输送技术是一个制造平台，使用专利保护的产品特定配方和工艺条件来制造纳米晶体，并使用专利聚合物涂层工艺来涂覆和稳定纳米晶体。药物纳米颗粒的聚合物涂层充当能量屏障以防止团聚，从而保持增强的溶解特性和长期产品稳定性，以及防止下游问题，例如不一致的生物利用度和/或给药。NanoContTM平台预计将成为一项颠覆性技术，因为它提供严格控制的粒度/粒度分布、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。没有任何竞争产品能够提供这种独特的优势组合。总之，MA？的NanoContTM药物递送技术提供了一种新的方法，用于在由药学上可接受的聚合物制成的聚合物涂层结构中纳米配制药物晶体。预计在连续生产平台上提出的技术将提供一种快速、易于扩展和广泛适用的工艺，用于开发和递送难溶性化合物，作为具有良好溶出度、安全性和PK特征的新型可专利药品。

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.