title: Pharmacokinetics of Ferrous Sulphate (Tardyferon®) after Single Oral Dose Administration in Women with Iron Deficiency Anaemia.
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(®) 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(®) 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.
authors.affiliation: Department of Pharmacology & Therapeutics, University College Cork, Ireland.
authors.forename: A
authors.initials: A
authors.lastname: Leary
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: L
authors.initials: L
authors.lastname: Barthe
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: T
authors.initials: T
authors.lastname: Clavel
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Sanchez
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: M
authors.initials: M
authors.lastname: Oulmi-Castel
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: B
authors.initials: B
authors.lastname: Paillard
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Edmond
authors.affiliation: Institut de Recherche Pierre Fabre, Research and Development, Toulouse, France.
authors.forename: V
authors.initials: V
authors.lastname: Brunner
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000378:metabolism; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005296:Ferrous Compounds / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009077:Mucins / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D013607:Tablets / Q000493:pharmacokinetics / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D004338:Drug Combinations; D005296:Ferrous Compounds; D009077:Mucins; D013607:Tablets; C020748:ferrous sulfate; C009380:ferrous sulfate, mucin drug combination