Abstract
Menaquinone-7 (MK7) is a member of the vitamin K family in which interest has considerably increased over the last decade, mainly due to its beneficial role in human health. MK7 can be produced by synthesis or fermentation, and its purity profile can differ depending on methodologies and extraction procedures. Finished formulations show a high heterogeneity of purity profiles, as well as frequent discrepancies in the nominal content, compared to the actual title. The present study compared purity profiles of different raw material and related them to their stability in normal (12 months/25 °C/60%RH) and accelerated conditions (6 months/40 °C/75% RH) in order to test their performance in the presence of different common excipients. Results showed higher purity profile results in enhanced stability, and this could explain title discrepancies found in finished products, which are present on the market worldwide.
Highlights
Vitamin K constitutes a family of compounds with a common chemical structure, 2-methyl-1,4-napthoquinone (Figure 1)
Analysis was performed using Graphpad software, and p values ≤0.05 were considered statistically significant, with p values ≤0.01 and ≤0.001 considered highly significant. These data were preliminary and limited to the number of samples tested, the present study was in agreement with previous reports showing a general instability issue in MK7 formulation and suggested that purity profile aspects should be taken into account while choosing
The trans form is the only active form of menaquinone able to act as a cofactor for carboxylation; on the contrary, cis isomers are associated with lack of activity, unknown toxicity profile, and may contribute to instability
Summary
Vitamin K constitutes a family of compounds with a common chemical structure, 2-methyl-1,4-napthoquinone (Figure 1). Despite their difference in molecular structure, the molecules of this family share a common function as a specific cofactor in the formation of γ-carboxyglutamyl (Gla) from specific glutamate residues in VKDP. The Gla residues confer calcium-binding properties; this common pattern characterizes different functions of vitamin K-dependent proteins (VKDP) [1,2,3,4,5]. K1 (phylloquinone), of plant origin, is the predominant dietary form of vitamin K [6,7,8]; the second main component of the vitamin K family is vitamin K2 (menaquinone), primarily of bacterial origin.
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