The Gold Standard

Welcome to The Gold Standard, a quarterly feature on leading, cutting-edge raw-materials suppliers. These are companies setting new standards, breaking new ground, solving industry issues, conducting business with integrity, and expanding markets through innovative products and applications.

Members of the
Functional Foods & Nutraceuticals editorial advisory board led the way in developing this list of top-flight companies worthy of mention. We hope our readers will benefit from their collective expertise.

Coenzyme Q10
Coenzyme Q10 is a fat-soluble, natural vitaminlike substance produced by the body. A literal powerhouse, co-Q10 accumulates in the cells' mitochondria, the cellular power plants that convert nutrients into energy. It acts as an essential cofactor in generating the body's energy via adenosine triphosphate, or ATP, making it a staple in many energy foods and supplemental formulas.

In this installment of The Gold Standard, the FF&N editorial advisory board helped assess the state of the co-Q10 market. We profile a leading Japanese manufacturer/ supplier, and three resellers whose innovative formulations have boosted bioavailability and opened new avenues of delivery systems to integrate this potent nutrient into the functional foods supply.

Wide-ranging benefits
Co-Q10 accumulates, to a large degree, in the heart muscle, increasing heart strength and benefiting a range of heart-health conditions. It accumulates to a lesser degree in the brain, leading researchers to investigate its use for cognitive degenerative diseases such as Parkinson's and Alzheimer's. New research published just this year suggests doses up to 3g/day may have some efficacy against these conditions. Co-Q10 also has demonstrated some antiwrinkle properties as well as UV protection.

Studies have shown that long-term use of statins — the most widely prescribed class of cholesterol-lowering drugs — reduces co-Q10 levels. As more research validates earlier studies, and the news filters to the medical community, use of co-Q10 with statin-drug treatment should serve to boost usage of the nutrient in much the same way that probiotics are now recommended when patients are prescribed antibiotics.

Getting it to work
Perhaps with no other nutrient is bioavailability so used as a marketing tool. Regular co-Q10 is a crystalline powder of low solubility and poor bioavailability. Because it is fat soluble, it faces bioavailability issues involving emulsification in the intestine and the formation of micelles prior to absorption. Among other factors affecting bioavailability are its molecular particle size, degree of solubilisation and the type of food taken with it.

These issues — coupled with the high expense of the supply — have led supplier resellers to add ingredients such as fat-soluble vitamin E or lipophilic mediums such as soy-bean oil, or otherwise amend it via nanotechnology or crystal solvents in order to boost its bioavailability.

When Japanese regulatory bodies reclassified the nutrient from a prescription drug to an over-the-counter supplement in 2002, consumer use and acceptance skyrocketed. As supply has worked to catch up, the raw-material price has moderated.

Manufacturing methods
The lion's share of co-Q10 on world markets is fermented (so-called 'natural fermented'), employing either live bacteria or yeast. Synthetic co-Q10 involves partial fermentation and then synthesis of a chemical extracted from the tobacco leaf, which is identical to that produced endogenously. The co-Q10 market in the US is dominated by the supplements sector, while Japanese food products contain co-Q10 (including a Coca-Cola brand beverage), and Europe has mostly skin-care products.

Kaneka: Supplying a booming market
Because the FDA recently approved the 16-month-long Phase II study of the effects of co-Q10 on Parkinson's disease — and moved its start date up to the end of 2006 — sales of the vitaminlike substance are expected to increase three- to fourfold over the next three years.

No company is in a better position to meet the increased demand expected after the results of the study are in than Kaneka, the Osaka, Japan-based pharmaceutical giant and number one manufacturer of co-Q10 in the world.

Kaneka is the only manufacturer of co-Q10 utilizing a natural fermentation process using yeast, which it pioneered in 1977. Other manufacturers of natural, fermented co-Q10 employ bacteria instead of yeast. The identity of Kaneka's yeast-enabled co-Q10 is as closely guarded a secret as the formula for Coca-Cola, according to Thomas Schrier, national sales manager at Kaneka Nutrients LP, the branch that markets the product. The end result, he says, is that the product is 99.7 per cent pure, and comes closest to matching the co-Q10 occurring naturally in the body.

"It's the only one that has a self-affirmed GRAS status," he says. The company ran its product, a bulk powder, through the rigours of testing by Cantox Health Sciences International, where it received a clean bill of health, and submitted results to the FDA, which did not object.

The establishment of its new, $80 million production facility in Pasadena, Texas, which should be complete within six months, will make Kaneka the only manufacturer of co-Q10 in the US. It has also established a US subsidiary to serve the North American market, as it has done in Europe.

The company already supplies nearly 70 per cent of the co-Q10 used in the US, which is the largest consumer of the product, selling its branded KanekaQ10 exclusively to end-product manufacturers (save an old agreement with Tishcon). The Texas plant will expand production output of co-Q10 by 100 metric tonnes annually. This increased capacity, Kaneka's duplication of manufacturing capabilities, and its exclusivity contracts with end-product manufacturers, should greatly reduce counterfeiting problems that sprang up last year when demand and prices rose dramatically, the company says.

DSM: Beadlet technology
DSM's innovation in the field is an oil-soluble, crystalline co-Q10 tablet-grade product called All-Q. It utilises a beadlet technology, called Actilease. The beadlets contain finely dispersed droplets of co-Q10 within a protective matrix.

"Actilease not only assists the bioavailability of co-Q10, it also protects the co-Q10 during tablet compression," says Bob Berman, senior marketing manager, new business development at DSM Nutritional Products. "It was the first available co-Q10 tablet-grade form."

Because it is water soluble, it has excellent stability in various food and beverage applications. This form is said to not impart off-flavours, making it also suitable for food applications. It's water solubility also is seen as opening up new markets and creating new product opportunities in the food and beverage industries. The more typical crystalline form is fat soluble and therefore difficult to add to many food types. DSM is working with clients to integrate it into foods as diverse as juice, sports and energy drinks, yoghurt and other dairy products, cereals, and energy bars.

DSM conducted one of the few co-Q10 comparison studies to go head-to-head with leading, bio-enhanced commercial varieties and not just the original co-Q10 commodity ingredient. In this case, DSM compared their All-Q ingredient to Tishcon's Q-Gel and Q-SorB. Twelve healthy male subjects participated in a randomised, three-period, crossover, bio-equivalence study. Plasma co-Q10 was determined from pre-dose until 36 hours after. The highest blood concentrations (Cmax) were seen after Q-Gel application, whereas time to Cmax was nearly identical across all treatments. The bioequivalence was about equal for Q-Gel and All-Q, and both were found to have better bioavailability than Q-SorB. So while DSM's and Tishcon's were close to the same, DSM's All-Q can be used directly in tablets. In addition, DSM has a form for the cosmetics market, called All-Q Plus, which contains co-Q10 plus vitamin E.

In sum, DSM's applications expertise is paving the way for co-Q10's formulation in the wide diversity of delivery systems, from multivitamins to single-ingredient softgels, and from foods and beverages to topical cosmetics.

Tishcon: Bioavailability pioneer
Tishcon was the first company to talk about bioavailability with co-Q10, and the New York-based reseller has set the standard ever since. It utilises a process that makes the particles smaller, which gives the molecules greater surface area and increased bioavailability. Commercial co-Q10 particle size is generally between 25 and 50 microns. Tishcon has brought it down to less than 1 micron, which increases the surface area of the molecules exponentially. This increases bioavailability and also makes it stay in suspension in liquids. This is coupled with a process, dubbed Bio-Solv, that dissolves the co-Q10 more easily and facilitates proper emulsification of lipids in the human gut.

Tishcon has conducted a series of studies showing their branded ingredient, Q-Gel, to be 300 per cent more bioavailable than normal co-Q10 gels and powders. Theirs is the bioavailability standard by which all others are measured.

"The idea came to us in the early 1990s that a lot of co-Q10 is enriching the toilet bowl," says Tishcon chairman, CEO and CSO Raj Chopra. "Almost 90 — 95 per cent of ingested co-Q10 was discarded by the body, not absorbed. We said if we could reduce the particle size of the co-Q10, theoretically at least we could increase absorption and thereby get a bigger bang for the buck. So instead of five or 10 per cent that was ingested and absorbed, you could get 25 or 30 per cent."

In one study, Tishcon compared Q-Gel to co-Q10 suspended in oil, powder-filled hard-shell capsules and powder-based tablets, using a daily dosage of 120mg/day for three weeks. After three weeks the plasma values were 1.37, 1.63, and 1.60mcg/mL, compared with Q-Gel's 3.31mcg/mL. The relative bioavailability calculated using the areas under the plasma co-Q10 curve were 7.16, 8.97, 9.19 and Q-Gel's 22.86. A follow-up trial, carried out to replicate the findings in the first trial, used standard softgel capsules containing the suspension and Q-Gel, for four weeks. After four weeks, plasma co-Q10 values were 1.26 compared to Q-Gel's 2.80. Areas under the curve values were 8.33 compared to 22.75.

"Before 1995, there was no interest at all in working with bioavailability of co-Q10, or any substance in the nutritional industry," says Chopra, chairman. "The thing is, you have to keep going after what you believe in no matter what the industry or the market thinks of you."

Chopra says the medical community, and even the FDA, looked upon co-Q10 with suspicion. In order to "get this molecule some respectability," he says, he embraced the pharmaceutical model by getting quality standards established. About three years ago, after years of prodding by Tishcon, the US Pharmacopoeia produced a co-Q10 monograph.

As part of the campaign, in 1999, the FDA accepted Tishcon's petition to receive orphan-drug designation for co-Q10 and mitochondrial diseases, paediatric congestive heart failure and Huntington's.

"That helps the cause because now people say the FDA is paying attention," says Chopra. "They've given orphan-drug designation for co-Q10 in treating all these incurable diseases, so it's not snake oil anymore."

PL Thomas: Nanotechnology
PL Thomas & Co (PLT) has what they consider a leg up on the bioavailability issue of co-Q10, through their partnership with the Israeli company Adumin Food Ingredients, which has created an exclusive, patent-pending nano-technology called NutraLease.

PLT president and owner Paul Flowerman cites studies, some as yet confidential, that these nanoemulsions are effective in delivering significantly higher doses of co-Q10 than other applications. Equally significant, however, is NutraLease's ability to make co-Q10, as well as other nutraceuticals, compatible with use in clear beverages.

"We're very excited about it," Flowerman says. "This is particularly good for the beverage industry. You get more bang for the buck and it's clear, as well."

NutraLease technology puts co-Q10 into a single-wall emulsion at less than 20 nanometers in diameter. This small size enables it to be transparent, soluble and readily absorbed by the body's cells. It is also stable to pH and temperature conditions, maintaining integrity through pasteurization, homogenization and other process conditions, so that there is no separation, sedimentation or instability in the final drink. A typical dosage of co-Q10 would be 30mg per 250ml, or three per cent of the final drink.

And a final point worthy of mention for The Gold Standard: for many applications, the nanoemulsions are 'self-assembling.' That is, by merely mixing, you can protect and solubilize the active ingredient.

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