Pharmacokinetics of Ferrous Sulphate (Tardyferon®) after Single Oral Dose Administration in Women with Iron Deficiency Anaemia
| Autor: | Andrew Leary, J. M. Edmond, Laurence Barthe, C. Sanchez, T. Clavel, B. Paillard, M. Oulmi-Castel, V. Brunner |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Adolescent Anemia Population Physiology Administration Oral Absorption (skin) Pharmacology Young Adult Pharmacokinetics Oral administration Drug Discovery medicine Humans Dosing Ferrous Compounds education education.field_of_study medicine.diagnostic_test Anemia Iron-Deficiency business.industry Mucins General Medicine Iron deficiency Middle Aged medicine.disease Drug Combinations Delayed-Action Preparations Serum iron Female business Tablets |
| Zdroj: | Drug research. 66(1) |
| ISSN: | 2194-9387 |
| Popis: | 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 (T max ) occurred 4 h post-dosing. Between 2 and 8 h post-dosing, mean serum iron concentrations fluctuated by only 20%. Additionally, C 8h and C 12h represented on average 78.6% and 47.5% of the C max , 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. |
| Databáze: | OpenAIRE |
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