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

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.