The objective of this SBIR Phase I proposal is to test the feasibility for development of an automated platform that can perform the following: 1. Identify botanical components of dietary supplements throughout the supply chain by use of chemical analysis and integrated pattern recognition software 2. Detect the presence of adulteration by use of HPLC (and UHPLC) analysis of bioactive compounds and by use of orthogonal data from other analytical instruments (e.g. terpene analysis by GC). 3. Automate the quantification of the key bioactive compounds. Innovative aspects of the proposed research are the restructuring of proven MIDI Inc. software for HPLC analysis of bioactive components of botanical dietary supplements and use of orthogonal GC data from metabolites, such as terpenes. The MIDI software has been cited in more than 4,000 publications and both the HPLC and GC microbiology systems have FDA 510 (k) clearance as medical devices for species-level identification.1,2 Thus, the basic system is shown to be scientifically valid but needs modification and additions to target botanical dietary supplements (proposed MIDI platform). Botanical reference materials (BRMs) will be analyzed and the patterns stored electronically, reducing the need for these expensive materials. Chemical analysis patterns of materials throughout the dietary supplement supply chain will also be electronically stored to enable changes due to processing and authentication in all steps of manufacturing. The proposed technology should improve precision of compound naming, lower labor costs, reduce human errors, improve turn-around-time for analysis, as well as meeting the objectives above. However, the keys to success are that it should improve human health due to improvements in quality control of botanical dietary supplements, make it possible for the industry to largely self-regulate and aid the FDA in regulation of the industry. The result should improve human health though removal of adulterated or low quality products from the market.
In a recent Council for Responsible Nutrition (CRN) survey, 71% of Americans take dietary supplements, and while most are safe and may be useful, some are low quality and others are adulterated. This SBIR proposal will test the feasibility of development of an innovative platform for species-level authentication of botanical dietary supplements, detection of adulteration, and quantitation of bioactive compounds. The software platform will be fully automated, give precision chemical analysis and be the basis for industry standards aimed at improving human health.
