The ingredient – MenaquinGold – is said to be manufactured to drug standards by Viridis BioPharma/Synergia Life Sciences in a dedicated GMP, Indian FDA-inspected facility in Mumbai. According to the companies, it is the only natural K2-7 from natto fermentation that is made as a drug and sold to large multinational pharmaceutical companies.
The ingredient is distributed exclusively in North American by Nu Science Trading. Talking to NutraIngredients-USA, Dale Kriz, senior managing director, Nu Science said that the ingredient had only limited availability for dietary supplement manufacturers because “demand for the product in the pharmaceutical sector was growing rapidly and thus supply was controlled”. However recent expansion at the Mumbai production facility has led to a widening in availability to the US supplement and food markets as a whole, he added.
A move towards pharma-grade?
Kriz said that supplement manufacturers were becoming more quality conscious following the introduction of GMPs. “We are seeing an increase in demand for documentation and certificates to show that the product is produced under the right quality standards.
“With this in mind, the pharmaceutical grade materials we use for MenaquinGold are of the highest quality standard and thus customers can rest assured that they are putting the safest and most efficacious products on the shelves and in the hands of consumers,” said
“Having participated in the development of more than five prescription formulations with vitamin K2-7, Nu Science Trading and Viridis BioPharma have extensive knowledge in the area of formulation and ingredient stability of vitamin K2-7,” said Kriz.
Kriz added that the companies have developed a 2500ppm granulated oil powder which reportedly offers high process stability and versatility, and is said to be the “only one of its kind on the market today”.
The ingredient’s stability has been checked under ICH guidelines and is Kosher certified, added Nu Science.
There are two main forms of vitamin K: phylloquinone, also known as phytonadione, (vitamin K1) which is found in green leafy vegetables such as lettuce, broccoli and spinach, and makes up about 90 per cent of the vitamin K in a typical Western diet; and menaquinones (vitamins K2), which make up about 10 per cent of Western vitamin K consumption and can be synthesised in the gut by microflora.
Menaquinones (MK-n: with the n determined by the number of prenyl side chains) can also be found in the diet; MK-4 can be found in animal meat, MK-7, MK-8, and MK-9 are found in fermented food products like cheese, and natto is a rich source of MK-7.
In NutraIngredients-USA’s recent focus on vitamin K, Francis Foley, president of Xsto Solutions – exclusive US distributor of Kappa’s recently launched K2Vital synthetic vitamin K Product Line – estimated the vitamin K market in the US at $10 million in raw material sales (vs finished product sales).
“What is really impressive is the growth in Vitamin K supplementation, estimated to be (my personal estimate) over 15 percent per year. We feel the K2 market can double to $20 million in less than five years,” said Foley.
The number of dietary supplements launched containing vitamin K has been relatively stable over the past four years. According to data obtained this week from Mintel’s Global New Products Database (GNPD), in 2007 86 products were launched, while 95 and 91 were launched in 2008 and 2009, respectively. So far this year 38 dietary supplements products have been launched containing vitamin K.
The market is dominated by branded ingredients: NattoPharma offers MenaQ7, Blue California offers Vitamin K2-All Trans, PL Thomas has Vitamin K2-MK7, and Kappa/ Xsto offers K2Vital.
Adding to this will be the wider availability of Viridis BioPharma/Synergia Life Sciences’ MenaquinGold.
Commenting on the price of the MenaquinGold ingredient, Kriz said that, despite being manufactured to pharmaceutical grade, the ingredient “is extremely competitive in pricing. We are right on par with other supplies of natural K2-7 and in most cases can even present the buyer with cost savings and provide them with a superior product,” he said.