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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).
Substance Information
Specification
Absorption, distribution and excretion data
High solubility
Stability in solution
Stability to heat
Less reactivity with
tannic acids
Less reactivity with
phytic acids
Sensory evaluation
High absorption
(specific mechanism
of SFC absorption)
Inhibition of absorption
of excessive iron in
healthy people
Selective absorption
Decreased GI
(gastrointestinal)
disorders
High absorption
during pregnancy and
after delivery
High transfer to
fetuses
Patients with
hypoacidity
No inhibition of SFC
absorption in the
presence of calcium
Post marketing
surveillance
*Note: SFC has been also used as the drug substance of a prescription drug Ferromia in Japan. The above data include
clinical data based on Ferromia preparations.
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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.
High solubility1)
Stability in solution2)3)
Stability to heat1)
Less reactivity with tannic acid4)
Less reactivity with phytic acid5)
Sensory evaluation3)6)
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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.
High absorption during pregnancy and after delivery12)-15)
Administration of a dairy supplemental dose to women with iron deficiency16)
High transfer to fetuses15)
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References:
1) Ishino Y, Takashima M, Terashima C, Orimo Y (1988). Physicochemical properties and stability of tetrasodium biscitrato iron (II).
Pharmaceutical Regulatory Science 19(1):44-52 [English Translation].
2) In-house data (2005): Stability of SFC and a fine iron powder preparation in solutions at various pH values by Omura K, Honjo
Laboratory Unit, Eisai Food & Chemical Co., Ltd. [English summary].
3) In-house data (2004): Sensory evaluation for SFC-added beverages Omura K, Honjo Laboratory Unit, Eisai Food & Chemical
Co., Ltd. [English summary].
4) Shimozono T et al. (1988). Evaluation of factors which affect the reactivity of iron with tannic acids. J of New Remedies & Clinics
37(6): 1030-1034 [English summary].
5) Terashima C et al. (1992). II. Sodium Ferrous Citrate: Iron Fortifier Materials: Tokyo, Japan: Japan Confectionery and
Innovative Food Ingredients Research Center, pp.1-10 [English summary].
6) In-house data (2002): Study report 20020261: Comparison of physico-chemical features of SFC to other iron materials
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(Marketing promotion data for SFC (Sanferol). Iwata T, Eisai Co., Ltd.[English summary].
7) In-house data (2004): Take K and Yoshimura H, Eisai Co., Ltd. [English summary].
8) Fujita T, Terato K (1973). Approach to mechanism of intestinal iron absorption in terms of physicochemical properties of iron
compounds. J of Clinical and Experimental Medicine 87(13):711-716 [English translation].
9) Terato K, Fujita T, Yoshino Y (1973). Studies on iron absorption. I. The role of low molecular polymer in iron absorption. Am J
Dig Dis 18(2):121-128 [English translation].
10) Miyao S, Iwata N, Maekawa T (1984). Results of a phase I clinical study of E-0708. Jpn J Clin Exp Med 61(6):315-330 [English
translation].
11) Motoya T et al. (1989). The effect of green tea drinking on absorption of sodium ferrous citrate. Prog. Med. 9(3): 1293-1296.
[English translation].
12) Shoda S, Kozu H (1989). Treatment with Ferromia for iron deficiency anemia. Parturient Blood 13(1): 77-82 [English
summary].
13) Terao T, Maki M, Suzuki M (1989). Multicenter clinical study on sodium ferrous citrate preparations as a treatment for anemia in
pregnant women - Comparison with ferrous sulfate. Obstetrical and Gynecological Practice 38(2): 191-206 [English summary].
14) Noda Y et al. (1994). The therapeutic effect of SFC on postpartum iron deficiency anemia. Perinatal Medicine 24(7):1001-1004
[English summary].
15) Hayashi Y et al. (1989). Iron metabolism in pregnant women and cord blood findings. Obstetrical and Gynecological Practice
38(9):1319-1323 [English summary].
16) Shirakura T, Kubota K, Tamura J, Kurabayashi H, Yanagisawa T, Sakurai T et al. (1988). Clinical research: Effects of iron-fortified
jelly on iron deficiency. Clin Nutr 72(1):65-68 [English translation].
17) Kariyazono H et al. (1993). Clinical research on iron absorption in patients who had gastrectomy. Surgical Metabolism and
Nutrition 27(2): 107-112 [English summary].
18) Johno I et al. (1992). Clinical research on iron absorption in patients who had a total gastrectomy. Medical Consultation and
New Remedies 29(5): 1235-1240 [English summary].
19) Hori M and Nishi M (1988). Therapeutic effects of oral administration of Ferromia tablets in anemic patients after subtotal or
total gastrectomy. Japanese J of Clinical and Experimental Medicine 65(9): 3033-3035 [English summary].
20) Maekawa T et al. (1985). Clinical study of E-0708 on iron deficiency anemia - a multicenter double-blind comparative study with
sustained-release ferrous sulfate iron preparations. The Japanese Journal of Clinical and Experimental Medicine 62 (8):
2615-2636 [English summary].
21) Saeki T et al. (1992). Post marketing surveillance of sodium ferrous citrate (Ferromia) - Detailed drug use surveillance on age
and pregnancy factors. Pharmaceutical Regulatory Science (Special Number): 137-150 [English summary].
22) Mitamura T, Kitazono M, Yoshimura O (1989). Influence of green tea on improvement of iron deficiency anemia associated with
pregnancy: Treatment with sodium ferrous citrate. Acta Obst Gynace Jpn 41 (6): 688-694 [English summary].
23) Ariyoshi T, Arizono K, Irishio K, Okanari E (1987). Drug Metab Pharmacokinet 2(1):3-10 [English translation].
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Sanferol and Ferromia are registered trademarks of Eisai Co., Ltd. in Japan.
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