Synthesis-derived MK-7 is Bioequivalent to Fermentation-derived MK-7
07 Oct 2016 --- A new study has demonstrated that synthesis-derived MK-7 is 100% bioequivalent to fermentation-derived MK-7, in both biological function and activity. The new development is expected to please the K2 MK7 supplements industry, as production by batch fermentation restricts the manufacturing scalability of MK-7, restricting overall growth of the vitamin K2 market.
The new bioequivalence study, published in the latest issue of the International Journal of Vitamin Nutrition, is the first to prove the bioequivalence between synthesis-derived and fermentation-derived vitamin K2 MK-7, and represents a significant achievement in the development of the vitamin K2 MK-7 market.
Though the process to manufacture vitamin K2 MK-7 by organic synthesis has been in commercial use for several years, manufacturing has historically centered on the earlier fermentation-derived process.
This is partly due to the fermentation production of MK-7 being generally easier, as the MK-7 molecule is difficult to replicate in the laboratory. However, until now, the markets have also lacked proof of the bioequivalence of synthesized MK-7.
Researchers compared K2VITAL, the only synthetic and biologically active all-trans menaquinone-7 (vitamin K2 MK-7) from Kappa Bioscience, with fermentation-derived MK-7.
The study looked at the pharmacokinetics and biological function of K2VITAL in healthy volunteers in order to determine bioequivalence to fermentation-derived MK-7.
In a first crossover design trial, K2VITAL and fermentation-derived MK-7 were administered as a single 180 µg dose to determine bioequivalence. The study demonstrated that K2VITAL and the fermentation-derived MK-7 are bioequivalent as defined by uptake in the body.
A second trial investigated the dose effects of K2VITAL on serum levels in order to investigate whether K2VITAL has the same biological activity as fermentation-derived MK-7.
Biological activity was measured as the effects on carboxylated osteocalcin (cOC) and uncarboxylated osteocalcin (ucOC) in serum, a primary biological action of vitamin K2.
The study showed that K2VITAL and fermentation-derived MK-7 equally influence blood serum levels of OC and ucOC.
Furthermore, for the 180 µg K2VITA group, average cOC level showed an increase of 29 percent from baseline to the end of study on day 43.
The comparison test groups showed a similar trend, providing additional confirmation that K2VITAL is bioequivalent to the fermented MK-7.
Dr. Egil Greve, CEO of Kappa Bioscience commented, saying, ‘’We have been completely confident in the bioequivalence of K2VITAL compared to fermented MK-7, as have our many partners and customers, and we are delighted to now see these results published in a well-respected journal.’’
He continued, “Kappa will continue to innovate, taking on the challenges of difficult but potentially profitable molecules such as MK-7 and providing market solutions for ingredient stability and meeting the price points to reach all consumers in all market channels.’’
Kappa claims that a synthesis-based MK-7 production process allows for greater scalability and a secure supply chain, as well as continual improvements in the synthesis process, leading to ingredient price reductions.
