Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Gen-Eye (Pty) Ltd<sup>1</sup>, Unit 7, Royal Palm Business Estate, 646 Washington Street, Halfway House, Midrand, 1685, Gauteng, South Africa 1 Company Registration number: 2009/009360/07
The polynuclear iron (III)-hydroxide cores are superficially surrounded by a large number of non-covalently bound sucrose molecules resulting in a complex with a molecular weight of approximately 43 kD.
This is sufficiently large to prevent renal elimination.
The resulting complex is stable and does not release ionic iron under physiologic conditions.
The iron in the polynuclear cores is bound in a similar structure to naturally occurring ferritin.
The pharmacokinetics of the iron (III)-hydroxide sucrose complex was studied in healthy volunteers following the administration of a single intravenous injection of 100 mg iron. Peak serum iron concentrations, averaging 538 µmol/l were reached 10 minutes after injection.
The volume of distribution of the central compartment corresponds to the serum volume (approximately 3 litres).
The iron injected is quickly cleared from the serum. The distribution half-life is approximately 6 hours.
The volume of distribution at steady state is about 8 litres. This indicates a low iron distribution in the body fluid.
As a result of the lower stability of the iron (III) hydroxide-sucrose complex compared with transferrin, competitive exchange of iron to transferrin was observed, resulting in iron transport of approximately 31 mg Fe (III) per 24 hours.
Renal elimination of iron, occurring in the first 4 hours after injection, corresponds to less than 5% of the total body clearance (approximately 20 ml/minute).
After 24 hours the serum iron levels decreased to the pre-dose iron concentration and, approximately 75% of the sucrose dose was excreted.
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