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

这项小型企业技术转移（STTR）一期项目将展示新型生物材料基赋形剂（NBBE）在提高药物疗效和安全性以及降低药物成本方面的优势。在制药行业，现代药物发现带来了大量的候选药物；然而，其中的80-90%是不溶于水的。此外，大约40%的新商业化药物分子的水溶性很差。溶解度低严重阻碍了药物的溶解，影响了药物的安全性和有效性。为了应对这一巨大挑战，一些赋形剂已经被开发出来；然而，它们只能解决部分溶解度问题。新的多功能，强效赋形剂是制药工业非常需要的。该项目的目的是评估NBBE作为稳定和溶解水溶性差的药物的药用辅料的商业潜力。早期的研究表明，NBBE对水溶性较差的药物具有非凡的溶解能力，这是其他药物赋形剂难以达到的。为了评估NBBE的商业潜力，本项目的目标是：(1)制备NBBE和NBBE药物制剂，并评估其稳定性和溶解度；(2)评估NBBE药物制剂的安全性和有效性。该项目将通过显著提高药物的疗效和安全性、减少药物配方障碍和简化药物生产流程来实现更广泛的影响/商业潜力。在这个项目中，大学教授和一位商业领袖汇集了材料科学、药物配方和商业开发方面的专业知识。他们为这个项目打下了坚实的基础。该STTR项目的主要研究人员与制药行业有着密切的关系，他们不断得到各大制药公司的重要指导。工业支持对于通过定义矩阵和成功商业化的可交付成果来指导该项目至关重要。NBBE是生物基的和可持续的，因为它们可以从天然的、丰富的植物来源中制造，这确保了NBBE的可持续性和经济优势，而不是许多石油基的竞争材料。在这个项目中，团队在开发平台技术、与潜在投资者沟通以及与潜在客户合作方面取得了很大的成功。除了医药应用之外，通过该项目开发的产品在食品、营养和个人护理领域也有很大的潜力。

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.