Pharmacokinetics of Ferrous Sulphate (Tardyferon(R)) after Single Oral Dose Administration in Women with Iron Deficiency Anaemia.

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Leary A, Barthe L, Clavel T, Sanchez C, Oulmi-Castel M, Paillard B, Edmond JM, Brunner V

Pharmacokinetics of Ferrous Sulphate (Tardyferon(R)) after Single Oral Dose Administration in Women with Iron Deficiency Anaemia.

Drug Res (Stuttg). 2016 Jan;66(1):51-6. doi: 10.1055/s-0035-1549934. Epub 2015 May 19.

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25989284 [ View in PubMed
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Abstract

Iron-containing preparations available on the market vary in dosage, salt, and chemical state of iron contained in the preparation, as well as in the iron delivery process (immediate or prolonged-release). The present study aimed at characterizing the serum pharmacokinetics of iron in non pregnant women with iron deficiency anaemia (IDA) following a single oral administration of a prolonged-release ferrous sulphate tablet. This multicenter, single dose, open-label study was conducted in 30 women aged between 18 and 45 years with IDA. A single 160 mg oral dose of ferrous sulphate was given as 2 tablets of 80 mg of Tardyferon((R)) under fasting conditions. Blood samples were collected before dosing and until 24 h post-dosing. Serum iron concentrations were determined using a routine colorimetric analytical method. Pharmacokinetic parameters were determined from the serum concentration profiles using a non compartmental approach. Serum profiles showed elevated levels of iron up to 12 h after drug intake. The median time to maximum serum concentrations (Tmax) occurred 4 h post-dosing. Between 2 and 8 h post-dosing, mean serum iron concentrations fluctuated by only 20%. Additionally, C8h and C12h represented on average 78.6% and 47.5% of the Cmax, respectively. This study demonstrates that a single oral dose of 160 mg Tardyferon((R)) administered under fasting condition to 30 women with IDA leads to an optimal long-lasting release of iron in the gastrointestinal tract in the targeted population. This allows the attainment and maintenance of elevated serum iron levels for up to 12 h after administration.

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