SBIR Phase II: New ingredients technology to enhance the safety, quality, and value of active substances for pharmaceuticals, food, and personal care

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be accomplished through a proprietary technology with its extraordinary capability to enable a large number of high-value, hard-to-formulate active ingredients for pharmaceutical, food, and personal care products. In the pharmaceutical and personal care industries, this technology is able to solubilize and enable poorly water-soluble drug substances to achieve enhanced therapeutic effect, improved safety profile, and reduced cost. In addition, it may strongly support the long-term activities of drug discovery and development through activating potentially efficacious, but hard-to-handle chemical entities. By supporting new drugs development and reducing manufacturing cost, this technology will benefit the public health and meanwhile create commercial values to the industry. In the food and supplement industries, this technology may enable the industry to replace non-healthy or even hazardous additives, such as artificial colors and preservatives, with natural and healthy alternatives, thus greatly contribute to long-term food safety and security as well as public health. To achieve commercialization success, a solid portfolio of intellectual properties has been established. Seasoned business leaders will work with renowned scientists to incorporate cutting-edge technologies into drug, food & nutrition, and personal care products. The proposed project will substantially support the development of this new technology. The core problem/opportunity this technology targets is a large number of high-value whereas poorly water-soluble active ingredients that have been challenging the drug and food industry for a long time. For example, around 80% of drug candidates identified by modern drug discovery technologies are poorly water-soluble. For food, a large number of vitamins, nutrients, antioxidants, and natural colors are poorly water-soluble. Overall, poorly water-soluble compounds constitute an enormous formulation challenge. To address this need, this team has created a platform technology that is highly effective and non-specific. The goal of this project is to further develop the technology, scale up the synthesis of a core material, obtain the data on its safety profile, and advance the commercialization activities by providing prototypes to potential customers. This project will be conducted through close collaborations among the start-up company, a major university, and a number of major pharmaceutical, ingredients, food, and personal care companies. The deliverables of this project include the specifications of core material, initial safety evaluations, and prototypes provided to customers. This project will support the start-up company to form a solid foundation for commercialization and long-term growth.