News

Vioxx® Recall May Provide Opportunity for Natural Alternatives: BioActives Re-Focuses Attention On Its Celery-Seed Fraction
October 12, 2004 (Worcester, MA) With the recent withdrawal from the market of Mercks’ Vioxx®, the most popular of the Cox-2 inhibitor drugs, many arthritis sufferers and others with pain from gout and muscle stiffness may be reevaluating their options and considering alternative therapies.To address this need, BioActives LLC of Worcester, MA, a developer and manufacturer of active ingredients used in a variety of nutraceutical products, has begun refocusing its efforts on expanding the market for its Concentrated Celery-Seed Fraction as a natural, alternative therapy for arthritis pain.

BioActives’ Concentrated Celery Seed-Fraction is based on a proprietary process that extracts phthalides (butylphthalide, sedanenolide and sedanolide) from celery seeds. Phthalides have been shown in clinical tests to reduce pain, increase mobility, and establish an increased sense of well-being in people experiencing symptoms of pain from rheumatoid arthritis, gout and muscle stiffness. Hospital studies in both Australia and India have found celery seeds effective in combating both the progression and symptoms of pain from these conditions.

“Celery seeds have historically been used in Ayurvedic and traditional Chinese medicine as a diuretic tranquilizer, anti-spasmodic, nerve tonic, and anti-rheumatic” says Daniel Kagan, Ph.D., president of BioActives, Kagan continues, “The proprietary and patented process BioActives uses to produce its Concentrated Celery Seed-Fraction results in the highest total phthalide concentration in the market as measured by GC.”

The phthalides in celery seeds act to restore the balance in the body “prostaglandin system – one of the most important chemical control systems in the body that regulates inflammation, pain, and swelling (as well as blood pressure, heart, digestive, and kidney function). More information about phthalides is available at BioActives’ web site www.phthalides.com and at Doctor Michael Murrary’ web site www.doctormurray.com

BioActives Concentrated Celery Seed-Fraction is available to manufacturers and marketers of nutraceuticals in two forms: powder for hard capsules or oil for incorporation into softgels. It is currently being sold in capsule form by such well-known companies as Natural Factors..

RELEASE 2

Not all lutein is alike: Low concentration lutein can mean shorter shelf-life while high concentration lutein can contain unacceptable solvent levels

October 28, 2004 (Worcester, MA) With interest in the antioxidant lutein for its claimed eye, skin and cardiovascular benefits at an all time high, and the results of a recent lutein supplementation study at the North Chicago VA Medical Center (published in April 2004 in Optometry – The Journal of the American Optometric Association) showing it effective in reversing symptoms of age-related macular degeneration (AMD), the number of companies distributing lutein crystals is increasing exponentially.

According to Daniel Kagan, Ph.D., president of BioActives LLC of Worcester, MA, the increase in the number of suppliers has lead to a wide disparity in the quality of lutein crystals available to manufacturers of supplement products.

Kagan says there are a number of different distributors representing foreign manufacturers currently claiming either low concentrations of lutein at 45% or less or very high-grade lutein at above 90%. Based on random testing and detailed review of some of these company’s patents, BioActives has found that some of these products can be subject to rapid degeneration affecting shelf life or contain high residual-solvent levels — both factors that are undesirable by supplement manufacturers..

Kagan suggests the following guidelines for companies that purchase lutein crystals -; the starting material for stabilized “beadlets” , 20% oil dispersion for softgels and other finished lutein products – for use in their own product manufacture. First, buyers should opt for lutein that is consistently between 60% to 80% pure, for the best results. They should check the suppliers’ patent or manufacturing process to be sure that the process is gentle thereby avoiding excessive solvent residue. They should verify the suppliers’ patent number to be sure the patent applies to making lutein (some don’t and take steps to ensure that the process described in the patent is actually the one being used to produce the lutein. Lastly they should ask for certificates of analysis for each of the aforementioned.

Lutein is purified from marigold oleoresin that contains fatty acid esters of lutein. The purification process creates free lutein and residual impurities that hold moisture. The more impure lutein product has to be dried at higher temperatures for longer periods of time to lower moisture to less than 5%. These harsh processing conditions initiate a slow oxidative degradation of lutein, resulting in a significantly reduced shelf-life in the final product. If the moisture level is not reduced to below 5% the product also degrades more quickly.

On the other hand, some lutein advertised at very high purity has either been found to have either highly variable lutein levels or high levels of residual solvents from batch to batch. Very high-grade lutein is often produced with multiple solvents, some to purify the free lutein from the oleoresin, others to re-crystallize the product and still others to wash the crystals.