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

这个小型企业技术转移(STTR)第一阶段项目将展示新型生物材料辅料(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，但其中80%-90%的候选药物的水溶性较差。此外，大约40%的新商业化药物分子的水溶性很差。低溶解度极大地阻碍了药物的溶解，不利于药物的安全性和有效性。为了应对这一重大挑战，已经开发了许多赋形剂；然而，它们只能解决部分溶解性问题。新型多功能、强效辅料是制药工业非常需要的辅料。本项目的目的是评估NBBE作为药物辅料稳定和溶解难溶药物的商业潜力。早期的研究表明，NBBE对难溶于水的药物具有非凡的增溶能力，这是其他药物辅料难以达到的。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，并评价其稳定性和溶解性；(2)评价NBBE-药物制剂的安全性和有效性。该项目的更广泛的影响/商业潜力将通过显著提高药物疗效和安全性、减少药物配方障碍和简化药物制造过程来实现。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。他们为这个项目奠定了坚实的基础。该STTR项目的主要研究人员与制药行业有着密切的关系，他们不断得到主要制药公司的重要指导。工业支持对于通过定义成功商业化的矩阵和交付成果来指导该项目至关重要。NBBE是基于生物的和可持续的，因为它们可以从天然的、丰富的植物来源中生产出来，这确保了NBBE相对于许多基于石油的竞争材料的可持续性和经济优势。与该项目相关联，该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巨大成功。除了医药应用，通过该项目开发的产品在食品、营养和个人护理领域也可能具有巨大的潜力。

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.