St. John's Wort "SuperFluids" Manufacturing Method Receives NIH Grant
This article was originally published in The Tan Sheet
Executive Summary
Aphios Corp. has been awarded a $1.1 mil., two-and-a-half-year "fast-track" Small Business Innovation Research grant from the NIH National Center for Complementary & Alternative Medicine. The subject of the grant is a manufacturing method using "SuperFluids," which the firm says allows better standardization of St. John's wort and other herbs.
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Aphios Corp. has been awarded a $1.1 mil., two-and-a-half-year "fast-track" Small Business Innovation Research grant from the NIH National Center for Complementary & Alternative Medicine. The subject of the grant is a manufacturing method using "SuperFluids," which the firm says allows better standardization of St. John's wort and other herbs. Aphios is collaborating with Paracelsian, developer of the BioFIT quality assurance assays for botanicals, herbs and other dietary supplements. Aphios, a Woburn, Mass. private R&D firm, is seeking a marketing partner for its SuperFluid products. The firm currently supplies one prescription drug, Taxol, overseas, and is working on SuperFluid kava kava and saw palmetto products, expected to be ready in the next two years. "The overall goal of the proposed R&D is to develop an improved St. John's wort product which can be manufactured in a standardized and reproducible manner, and in strict accordance with current Good Manufacturing Practices (cGMP) of the FDA," Aphios' abstract says. The firm proposes to "improve the quality and manufacturing of St. John's wort by utilizing supercritical fluids and near-critical fluids [with and without] two polar cosolvents such as alcohols. These fluids are gases, such as carbon dioxide, which when compressed, exhibit enhanced thermodynamic properties that can be 'fine-tuned' for rapid and selective extraction of bioactive molecules," the abstract says. The SuperFluids method will enable "more rigorous standardization of nutraceuticals and potential herbal Rx products such as St. John's wort" and will lead to new "formulations which may not be possible with conventional organic phase manufacturing," the firm states. "Such products will also be free of toxic organic solvents, environmentally-friendly and truly 'green.'" NIH is devoting significant resources to investigating St. John's wort. NCCAM has been recruiting patients for its Phase III clinical trial on the botanical and moderate depression conducted at Duke University (1 (Also see "NCCAM Advisory Council Approves Center's First Three Project Initiatives" - Pink Sheet, 6 Sep, 1999.)). In addition, NIH's Office of Dietary Supplements and NCCAM have awarded $1.5 mil. to a dietary supplement research center that among other things will look at St. John's wort and mild depression (2 (Also see "NIH ODS/NCCAM Fund Two Botanicals Research Centers" - Pink Sheet, 11 Oct, 1999.)). |