SBIR-STTR Award

SBIR phase I will lay the groundwork for standardized Echinacea production in Phase II. The source of crude material for subsequent analytical chemistry testing will be first addressed: Echinacea seeds will be tested and identified for purity, then germinated and cultivated at different seasons/soil/field conditions, and morphologic, organoleptic, chromosome/DNA, and microscopic characteristics will be systematically monitored and recorded. Simultaneously, all marker compounds and testing methodology to be used later will be developed in the first 6 months. The marker compound testing will begin in the last 6 months using samples from Gaia Herbs organic farm. The testing will include samples representing the different factors that influence the potential medicinal activities of Echinacea, e.g., parts of plant, species, and horticulture. Different extraction preparations will be developed based on marker compound analysis, and products developed based on extraction quality. The most desirable delivery forms will then be developed based on retesting analysis. Thus, specific aims of Phase I include: 1) preparation of raw material source for use in Phase II, data collection on plant identity; 2) preparation of marker compounds and testing methods; 3) marker compound testing to identify promising end products using different extraction solvents and strategy (i.e., best combination extraction types correlated with chemical component concentrations in plant parts and species); 4) evaluate optimum delivery presentation and product stability; 5) execution and direction of Phase II to deliver Phase I milestone; 6) share the knowledge and practices gained with the herbal industry and regulatory agencies. The growing Echinacea planted in Phase I will provide samples for analytical testing and product development for three years in Phase II, and more critically, the carefully monitored and characterized 1,2, and 3 year old plants growing in different soil conditions and harvesting times must be available to start Phase II. Long-term goals include new technology development viable for herbal industry and herb farms. The ultimate hope is to provide consumers, researchers, herbal industry, and health- care providers with easily recognized product quality and identity, and to scientifically establish or disprove the medicinal value of Echinacea. PROPOSED COMMERCIAL APPLICATIONS: In the process of manufacturing reproducible Echinacea products, new innovative technologies will also be developed through out the production process. All of the following can be modified and further developed for commercial application: 1) Identity testing of species/seeds that is simple, fast, and economical; 2) marker component analytical testing methodology that is commercially viable; 3) condition and materials used in the greenhouse for high-yield germination; 4) soil condition and materials used for quality raw material; 5) alternatives to pesticides/herbicides for organic farming that is not time consuming nor expensive; 6) Echinacea product that is manufactured in the same quality as the research products; and 7) product delivery presentation (form and package) that is convenient for consumers, which is also stable in quality, concentration, and purity to the date of expiration.

SBIR phase I will lay the groundwork for standardized Echinacea production in Phase II. The source of crude material for subsequent analytical chemistry testing will be first addressed: Echinacea seeds will be tested and identified for purity, then germinated and cultivated at different seasons/soil/field conditions, and morphologic, organoleptic, chromosome/DNA, and microscopic characteristics will be systematically monitored and recorded. Simultaneously, all marker compounds and testing methodology to be used later will be developed in the first 6 months. The marker compound testing will begin in the last 6 months using samples from Gaia Herbs organic farm. The testing will include samples representing the different factors that influence the potential medicinal activities of Echinacea, e.g., parts of plant, species, and horticulture. Different extraction preparations will be developed based on marker compound analysis, and products developed based on extraction quality. The most desirable delivery forms will then be developed based on retesting analysis. Thus, specific aims of Phase I include: 1) preparation of raw material source for use in Phase II, data collection on plant identity; 2) preparation of marker compounds and testing methods; 3) marker compound testing to identify promising end products using different extraction solvents and strategy (i.e., best combination extraction types correlated with chemical component concentrations in plant parts and species); 4) evaluate optimum delivery presentation and product stability; 5) execution and direction of Phase II to deliver Phase I milestone; 6) share the knowledge and practices gained with the herbal industry and regulatory agencies. The growing Echinacea planted in Phase I will provide samples for analytical testing and product development for three years in Phase II, and more critically, the carefully monitored and characterized 1,2, and 3 year old plants growing in different soil conditions and harvesting times must be available to start Phase II. Long-term goals include new technology development viable for herbal industry and herb farms. The ultimate hope is to provide consumers, researchers, herbal industry, and health- care providers with easily recognized product quality and identity, and to scientifically establish or disprove the medicinal value of Echinacea. PROPOSED COMMERCIAL APPLICATIONS: In the process of manufacturing reproducible Echinacea products, new innovative technologies will also be developed through out the production process. All of the following can be modified and further developed for commercial application: 1) Identity testing of species/seeds that is simple, fast, and economical; 2) marker component analytical testing methodology that is commercially viable; 3) condition and materials used in the greenhouse for high-yield germination; 4) soil condition and materials used for quality raw material; 5) alternatives to pesticides/herbicides for organic farming that is not time consuming nor expensive; 6) Echinacea product that is manufactured in the same quality as the research products; and 7) product delivery presentation (form and package) that is convenient for consumers, which is also stable in quality, concentration, and purity to the date of expiration.

Thesaurus Terms:
alternative medicine, chemical structure function, drug design /synthesis /production, drug discovery /isolation, drug quality /standard, method development, plant extract analytical method, chemical property, pharmacokinetics, plant ecology, plant physiology