Microencapsulated Vitamin K2 MK-7

The ultimate vitamin K2 for micronutrient formulations

Kappa Bioscience has teamed up with a leading international life sciences company
to develop a double coated formulation of vitamin K2 MK-7. K2VITAL Delta is pure
MK-7 with a unique microencapsulation system. Following the lead from other fat
soluble vitamins, vitamin K2 MK-7 now has the same protection the first and only
calcium and other mineral formulations.

Based on these findings, Kappa analysed the

content of MK-7 in a large number of mineral
and MK-7 containing formulations across all the
major markets.

Market Sample Analysis Results

Kappa Bioscience has analysed and tested more
than 100 samples of various formulations,
containing calcium and other minerals (mixtures,
tablets and capsules), in combination with vitamin
K2 MK-7. The samples were tested for content of
MK-7 compared to label claim. Finished product
samples were received from USA, EU and Asia.
The analytical campaign shows that a majority of
finished formulations have vitamin K2 recovery
issues when mineral salts are a major ingredient.
Figure 1 shows results from analysis of some
selected products. For each finished product, the
figure shows % content of MK-7 in relation to
the label claim. As can been seen in the figure,
there is a large variation in the content of MK-7
compared to the specification on the label.
The test results showed an average recovery rate
of only 42% in commercial products. Some
products showed vitamin K2 content as low as
10% of label claim. Investigations conducted by
Kappa Bioscience indicate that this low recovery
is related to the inherent properties of vitamin K2
when exposed to the alkali environment in such
formulations, the often high pressure and temperature used in tableting procedures, the various

VITAMIN K2 MK-7 CONTENT OF CALCIUM PRODUCTS

(% of label claim)

Average recovery rate (42%)

D
el
ta
Pr
od
Pr uc
od t 1
Pr uc
od t 2
Pr uc
od t 3
Pr uc
od t 4
Pr uc
od t 5
Pr uc
od t 6
Pr uc
od t 7
Pr uc
o t8
Pr duc
od t
9
Pr uc
od t 1
Pr uc 0
od t 1
Pr uc 1
od t 1
Pr uc 2
od t 1
Pr uc 3
od t 1
Pr uc 4
od t 1
uc 5
t1
6

It recently came to Kappa Biosciences attention

that during manufacturing, when combining
MK-7 and specific other dietary nutrients,
particularly minerals salts, some finished products
had stability issues. After extensive testing, we
discovered that several of the products containing
minerals and MK-7 in the market showed
comparable results, regardless of MK-7 origin or
geographic location.

qualities of minerals utilized, combined with the

rough surface of most minerals were leading to
excessive losses.

TA
L

Vitamin K2 as menaquinone-7 (MK-7) is the

new way to ensure the body gets sufficient
vitamin K to maintain optimal bone and cardiovascular health. Of all vitamin Ks, MK-7 has
proven to stand out with a superior bioavailability
and exceptionally long half-life in the body. Even
at very low dietary intake doses of MK-7, the
uptake in target organs such as bone and vascular
smooth muscle cells demonstrate positive health
benefits.

VI

K2VITAL DELTA

Product Development Fact Sheet

DE LTA

microencapsulated vitamin K2 MK-7 in the market, offering unsurpassed stability in

K2

Figure 1: Content of vitamin K2 MK7 (mcg) in

commercial calcium products; expressed as % of label
claim. K2VITAL Delta containing product does not
contain overage. It is generally expected that commercial products contain 10-15 % overage to secure label
claim.
These results demonstrate the importance of
a MK-7 formulation which can protect the
molecule during manufacturing and storage.
Following this discovery, Kappa initiated a
comprehensive project for the development of a
new MK-7 formulation which could be compatible with any calcium source, and well suited for
manufacture of all types of dietary nutrient tablets
such as multivitamins.

Development of a new stable

formulation for MK-7
As the only manufacturer of a pure crystalline
vitamin K2 MK 7, Kappa Bioscience has been
able to initiate and complete a formulation development program which solves these stability
issues. As key criteria, a superior formulation of
MK-7 must be easy to handle, and stable during
processing as well have good storage properties
over time. During finished product manufacturing it is important that the product have good
flow properties to minimise losses. It must
secure a homogenous blended product, and be
resistant to pressure and temperature during the
tableting process. After testing and analysis of a
large number of potential carriers and coatings,
Kappa Bioscience concluded that only microencapsulation could result in a stable product under
the given conditions.

A life sciences partner was chosen as our preferred

collaborator. Being one of the leading global
vitamin manufacturers, and having their own
range of fat soluble vitamins, the same technologies were tested on the pure vitamin K2 MK-7
raw material.
During the development process, we eventually
selected a superior double coated microencapsulated MK-7 that showed excellent flow properties and with no loss of MK-7 during processing
and during storage in combination with other
nutrients, in particular mineral salts. K2VITAL
Delta was formulated with calcium carbonate,
blended and tableted, and compared to noncoated MK-7. Stability results of K2VITAL
Delta microencapsulated MK-7, versus unprotected vitamin K2 product, are shown in Figure 2.
STABILITY OF VITAMIN K2 MK-7 IN CALCIUM CARBONATE TABLETS
(% recovery of MK-7)

2
25C

Delta
T=0M

Delta
T=1M

Delta
T=3M

4
40C

Cal-supl Cal-supl Cal-supl Cal-supl

T=0M T=1M T=6M T=12M

Figure 2: Stability of K2VITAL Delta formulated

with calcium carbonate (CaCO3) and a commercial CaCO3 / vitamin K2 product up to 12 months
at 25C & 40C storage. Excellent recovery of
MK7 containing K2VITAL Delta (approx. 100%
recovery, no overage) compared to commercial
CaCO3 /vitamin K2 product (85 % recovery, T=0,
overage unknown).

As can be seen in Figure 2, K2VITAL Delta

demonstrates excellent stability in calcium
carbonate tablets, tested up to three months at
accelerated temperature. In contrast, vitamin K2
in similar tablets, but without protection, resulted
in very low recovery. After 6 months at 25C the
recovery was only 64%. After 12 months at 40C
more than 70% of the vitamin K2 was degraded.
These results support the superiority of the
microencapsulated product compared to MK-7
products without sufficient protection (Figure 2).

Why MK-7 is not stable at certain

conditions
The porous structure of calcium can have a detrimental effect on unprotected nutrients. One of
the most common sources is calcium carbonate.
Calcium carbonate is an alkaline compound
and holds one of the highest concentrations of
elemental calcium. Calcium carbonate is available
in different quality levels, which have varying
degrees of influence on MK-7 stability.
Both the naphtoquinone ring and the fatty tail
of MK-7 may be attacked during processing
and storage. It is known that naphtoquinones are
sensitive to alkaline conditions. During the manufacturing process, the combination of alkaline
conditions, high pressure and high temperature
may be responsible for the degradation of the
MK-7. We have observed that the degree of degradation varies, depending on the source of calcium
as well as exposed processing conditions. Thus,
in order to avoid costly losses of active Vitamin
K2, it is necessary to protect the MK-7 molecule
with microencapsulation, resistant to all possible
negative effects during manufacture and storage.

Kappa Bioscience AS
Oslo Innovation Center
Gaustadallen 21
0349 Oslo Norway
Phone: +47 2108 0680
info@kappabio.com
www.k2vital.com
www.kappabio.com

ABOUT KAPPA BIOSCIENCE

Kappa Bioscience AS, a Norwegian
entity,

is the innovative leader and

first mover with its patent protected

high purity, all-trans vitamin K2 as
menaquinone-7 (MK-7). Driven by our
core vision to make Vitamin K2 MK-7
available for everyone, we own and
manage the whole value chain - from
production to sales. Kappa Bioscience
has

substantial

resources

and

knowledge about vitamins and vitamin

K2VITAL - The Vitamin of Tomorrow

K2 in particular. We deliver our vitamin

K2, branded as K2VITAL on various

K2VITAL is currently the only product based on pure MK-7 to facilitate the
optimal bioavailability and effect in non-activated GLA proteins such as

commercially suitable carriers, such

osteocalcin and MGP.

as MCC, MCT & microencapsulated

Application Field

K2VITAL MCC
Microcrystalline
cellulose powder

K2VITAL MCT OIL

Medium chain
triglyceride oil

K2VITAL DELTA
Microencapsulated
powder

Food based (low fat basis)

Food based (adequate fat basis)
Beverages (no fat base)*
Beverages (with fat base, eg Dairy)
Powdered Beverage Formulation
Compressed Tablets (without minerals)
Compressed Tablets (with minerals)
Soft Gel Capsules
Hard Gel Capsules
Dietary Powder Formulation
*Stability tests are ongoing

Country of origin: USA & Europe

Disclaimer: The information in this document is the sole and exclusive property of Kappa Bioscience and is believed to be reliable. However,
recipients should seek their own independent advice on regulatory, scientific and related matters. Statements contained shall not be considered as
warranties of any kind, expressed or implied, nor will Kappa Bioscience bear any liability for any reliance on the contents of this document. Kappa
Bioscience recommends that products containing Vitamin K2 MK-7 (K2VITAL) contain a labelling notice, making consumers aware of the potential
interference with anti-coagulant treatment therapies.
References: For Appendix information, please go to: www.kappabio.com/references

powder.