A new bioequivalence study published in Vitamin Nutrition Research represents a significant achievement in the development of the vitamin K2 MK-7 market
Although 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.
Fermentation production of MK-7 is generally easier as the MK-7 molecule is difficult to replicate in the laboratory, and the markets have lacked proof of the bioequivalence of synthesised MK-7.
This new study demonstrates, for the first time, that synthesis-derived MK-7 is 100% bioequivalent to fermentation-derived MK-7, equal in both biological function and activity.
This is an important development for the supplements industry because production by batch fermentation restricts MK-7 manufacturing scalability, and supply restrictions create obstacles to overall growth of the vitamin K2 market.
A synthesis-based MK-7 production process allows for greater scalability and a secure supply chain, and continual improvements in the synthesis process will drive ingredient price reductions.
Kappa Bioscience is the pioneer in development and production of the only synthetic and biologically active all-trans menaquinone-7 (vitamin K2 MK-7), marketed under the K2VITAL brand name. The study investigated 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 180µg 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. Further, for the 180µg K2VITAL group average cOC level showed an increase of 29% 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, comments: ‘'We have been completely confident in the bioequivalence of K2VITAL compared with 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.’