CoQ10 Bioavailability, Formulation (Co-operation, Competition in the CoQ10 Market)

Kaneka has also supported research on the safety and bioavailability of its CoQ10 ingredients. In one study, conducted out of Haradoi Hospital, researchers assessed the safety of Kaneka Q10 in a double blind, placebo-controlled, randomized study in 88 healthy adults.¹⁹ Kaneka Q10 in capsule form was taken for four weeks at doses of 300, 600 and 900 mg/d; no serious adverse events were reported, and adverse events were even across the placebo and intervention groups and judged to have no relationship to Kaneka Q10. Plasma CoQ10 concentration after eight-month withdrawal was almost the same as before administration.

In a second study, Kaneka researchers evaluated the safety and bioavailability of ubiquinol (as Kaneka QH™) in a single blind, placebo-controlled study; healthy volunteers received a single oral dose of 150 or 300 mg, and then oral administration of 90, 150 or 300 mg/d for four weeks.²⁰ There were no clinically relevant changes in standard lab tests, while mean plasma ubiquinol concentration-time curves increased non-linearly after single administration. There was also significant absorption seen, in non-linear dose fashion, over the four week study.

In addition to testing bioavailability, companies are also committing to studying the safety of their CoQ10 ingredients in a variety of matrices. Several firms are now offering GRAS (generally recognized as safe) CoQ10 ingredients for use in food and beverage products. Robert Berman, senior marketing manager, DSM, noted the company’s ALL-Q® is both self-affirmed GRAS and certified OU Kosher. Kaneka’s Q10 is also self-affirmed GRAS, as are offerings from Blue California and Asahi Kasei Pharma Corp.

Whether they’re putting CoQ10 into foods or supplements, manufacturers must be mindful of certain processing limitations when working with CoQ10. “Ubiquinone is susceptible to degradation when exposed to elevated temperatures and to light for prolonged periods,” Chopra said. “In the case of ubiquinol, the situation is very critical because the least bit of exposure of ubiquinol to atmospheric oxygen can lead to its oxidation to ubiquinone. One needs to operate in an inert (nitrogen) atmosphere and employ suitable formulation technologies, such as our patented technology that employs ascorbyl palmitate as an antioxidant.”

Finally, there is the issue of quality control. “When there was a shortage of CoQ10, many sellers of raw materials were selling other forms (e.g., CoQ9, etc.) or adulterated material,” Koon recalled. “Testing is the only way to be sure of the purity and quality of the material. CoQ10 also occurs in two isomeric forms. The material called natural CoQ10 is in the trans form, whereas the synthetic CoQ10 contains a mixture of both trans and cis isomers. USP limits the presence of other CoQ10 analogs and the cis-isomer and related impurities to less than 1.5 percent. The cis isomer can only be created in a synthetic process in the laboratory or as a by-product of manufacturing.”

Chopra added companies seeking exclusively natural CoQ10 should test for the absence of the synthetic cis isomer, while also assessing the material’s quality via testing. “The quality of CoQ10 ingredients can be verified by subjecting it to U.S. Pharmacopoeia (USP) monograph testing,” he said. “If the raw material passes all the tests, it can be considered a good quality material.”

Rising consumer interest, combined with greater raw material availability and stable pricing, will yield continued growth for CoQ10. Steinford noted, “CoQ10 remains a dynamic ingredient with a promising future. While CoQ10 is currently considered one of the most clinically studied ingredients on the market, the reality of new studies indicates the likelihood of more positive news and support of CoQ10.”

Editor's Note: A full list of references begins on the next page.