Bioavailability, absorption mechanism, and toxicity of microencapsulated iron (I) sulfate: studies in mice.
The iron compounds used for food fortification have to meet certain requisites related to their bioavailability, absorption mechanism, and toxicity, since they will be consumed by a massive population group. With these purposes, we evaluated a new product used for the iron fortification of milk and lacteous derivatives, called SFE-171, which is a ferrous sulfate, microencapsulated with phospholipids. The bioavailability studies were carried out using four groups of 30 female mice each. In two groups, we studied the absorption of ferrous ascorbate and ferrous sulfate, both in water as reference standards, which show absorptions of 13.1+/-4.9% and 13.2+/-4.3%, respectively. With the third group, we studied the absorption of ferrous sulfate in milk; its value, 7.9+/-3.2%, is significantly lower than that of the remaining groups, with a p < 0.01. The studies with SFE-171 in milk, were performed on the fourth group, with a result of 11.6+/-4.5%, demonstrating that its absorption does not differ significantly from that of the reference standards. The absorption mechanism was determined by means of in vivo self-displacement studies of the ferrous ion and the SFE-171, taking ferrous sulfate as the reference compound. For this study, 210 female mice were used, and no significant difference between the absorption mechanism of both products could be observed. Toxicity studies of the new product with regard to ferrous sulfate were carried out with two groups of 70 female mice each and two groups of 70 male mice each. The lethal dose 50% LD50 for SFE-171 and for ferrous sulfate was 1200 and 680 mg/kg for female mice and 1230 and 670 mg/kg for male mice, respectively, demonstrating that the toxicity of the first product is substantially lower than that of the reference standard. We conclude that the iron product under study has a high bioavailability, an absorption mechanism equal to that of nonhemic iron, and lower toxicity than ferrous sulfate.
Boccio
J R
JR
Physics Department, School of Pharmacy and Biochemistry, University of Buenos Aires, Junín, Argentina.
Zubillaga
M B
MB
Caro
R A
RA
Lysionek
A
A
Gotelli
C A
CA
Gotelli
M J
MJ
Weill
R
R
D000704:Analysis of Variance; D000818:Animals; D001682:Biological Availability; D004339:Drug Compounding; D005260:Female; D005296:Ferrous Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000633:toxicity; D007408:Intestinal Absorption; D007928:Lethal Dose 50; D008297:Male; D051379:Mice
D005296:Ferrous Compounds; C020748:ferrous sulfate