Sanferol® (Sodium Ferrous Citrate, hereinafter referred to as SFC), an iron fortifier, is odorless and greenish white powder, and soluble chelated iron (non-ionic iron). It contains 10.0 to 11.0% iron.1) It is synthesized from ferrous sulfate and sodium citrate. Because it is free from allergens, genetically modified organisms (GMO), and products of biological origin, Sanferol® is a very safe substance. It can be widely used as a food additive and supplement ingredient.
In Japan, Sanferol® has been used in various foods such as baby milk powder, school and hospital food, beverages, cereals and supplements. On May 10, 2013, the US FDA recognized SFC as a Substance Generally Recognized as Safe (GRAS).
Sodium Ferrous Citrate (SFC), the ingredient of Sanferol®, is stable to heating to about 270°C (518°F) and slightly hygroscopic. Due to its high solubility at acidic to basic pH values (between 1 and 8)1) and stability in solutions,2)3) it can be used in beverages such as sport and energy drinks. In addition to its heat stability, it reacts less with other food ingredients, for example, tannic acid4) and phytic acid,5) than with other iron materials, leading to good processability. Accordingly, Sanferol® can be used in processed foods such as retort foods, cereals, and baked cakes.
It is known that the absorption of iron in general is inhibited in the presence of calcium. The absorption of SFC, the ingredient of Sanferoi®, is not affected in the presence of calcium levels present in food.7) Sanferol® can be prescribed as supplemental tablets along with calcium.
Sanferol® exhibits high absorption. SFC, the ingredient of Sanferol®, is soluble at a broad range of acidic to basic pH values because it seems to be present in the form of a low-molecular weight complex of iron chelated with citric acids. This chelate can be absorbed from the gastrointestinal tract, unlike high-molecular weight polymers resistant to absorption from the gastrointestinal tract. These insoluble polymers are formed after oxidation in a basic solution.8)9) Iron is mainly absorbed from the small intestine, especially from the duodenum and the superior portion of the jejunum. In the small intestine, SFC is considered to be mostly present in the form of chelated iron (non-ionic iron), which can be absorbed into intestinal cells as chelated iron. Because of its characteristic mechanism of absorption, SFC exhibits higher absorption than other iron materials such as ferrous sulfate and ferrous fumarate.
SFC, the ingredient of Sanferol®, is absorbed well in persons with iron deficiency but is absorbed little in persons whose blood iron parameters such as serum iron and ferritin are high-normal.10)11) These features prevent healthy normal persons from absorbing an excessive amount of iron from supplements containing iron. Thus, Sanferol® can be safely ingested by anybody who takes iron supplements.
SFC, the ingredient of Sanferol®, is absorbed well by women with iron deficiency or anemia. Many reports show that SFC is effective for the treatment of anemia not only in non-pregnant women with anemia but also in pregnant and puerperal women with anemia.12)-15) It has also been reported that SFC preparation improved iron deficiency in a pregnant woman with iron deficiency anemia whose hemoglobin level had not increased after administration of other iron preparations such as ferrous fumarate.12) A dairy supplemental dose of SFC improved iron deficiency in young women with iron deficiency.16) In addition, it has been reported that SFC is transferred readily to the fetus through the placenta.15) Thus, Sanferol® is expected to be effective as an iron ingredient in supplements for women with iron deficiency.
Since it can be soluble in the form of chelated iron (non-ionic iron) even in weak basic pH conditions, SFC, the ingredient of Sanferol®, releases fewer iron ions than other iron materials such as ferrous sulfate and ferrous fumarate. Thus, it irritates the gastric mucosa less than other iron materials.12) It reacts little with other ingredients contained in food and tea, and accordingly its absorption is hardly affected by foods and drinks. SFC can be absorbed well even after meals10) and in persons with hypoacidity such as the elderly with decreased secretion of gastric acids, patients undergoing therapy with antacids, and patients with gastrectomy.17)-19)
SFC, the ingredient in Sanferol®, has been used as the drug substance in Ferromia®, a prescription drug, in Japan since 1986. There are abundant clinical efficacy and safety data on SFC.12)-22)
Absorption, distribution and excretion data demonstrate the high absorption of SFC.23)
Sanferol is registered trademarks of Mitsubishi Chemical Co., Ltd.
Ferromia is registered trademarks of Eisai Co., Ltd. in Japan.