STTR Phase I: Evaluating New Pharmaceutical Excipients For Dissolving Poorly Water-Soluble Drugs

This Small Business Technology Transfer (STTR) Phase I project will demonstrate the superiority of new biomaterial-based excipients (NBBE) to improve drug efficacy and safety and to reduce drug cost. In the pharmaceutical industry, modern drug discovery has brought a large number of drug candidates; however, 80-90% of them are poorly water-soluble. In addition, roughly 40% of newly commercialized drug molecules are poorly water-soluble. Low solubility greatly hinders drug dissolution and is detrimental to drug safety and efficacy. To address this grand challenge, a number of excipients have been developed; however, they can only solve part of the solubility problems. New multi-functional, potent excipients are highly desirable for the pharmaceutical industry. The goal of this project is evaluate the commercial potential of NBBE as pharmaceutical excipients to stabilize and solubilize poorly water-soluble drugs. Early work has shown extraordinary capability of NBBE in solubilizing poorly water-soluble drugs, which can hardly be achieved by other drug excipients. To evaluate the commercial potential of NBBE, the objectives of this project are to: (1) prepare NBBE and NBBE-drug formulations, and evaluate their stability and solubility, and (2) assess the safety and efficacy of NBBE-drug formulations. The broader impact/commercial potential of this project will be realized through significantly enhanced drug efficacy and safety, reduced drug formulation hurdles, and simplified drug-manufacturing process. In this project, university professors and a business leader bring together expertise in materials science, drug formulation, and business development. They have created a solid foundation for this project. Leading researchers for this STTR project have close relationships with the pharmaceutical industry, and they constantly receive important guidance from major pharmaceutical companies. The industrial support is critical to directing this project through defining the matrices and deliverables for successful commercialization. NBBE are biobased and sustainable since they can be manufactured from natural, abundant plant sources, which secure the sustainability and economic advantages of NBBE over numerous petroleum-based competing materials. Associated with this project, the team has been highly successful in developing the platform technology, communicating to potential investors, and collaborating with potential customers. Beyond pharmaceutical applications, the products developed through this project may also hold great potentials in the areas of food, nutrition, and personal care.