Stability of diluted iron polymaltose in PVC infusion bags

Background: In Australia, iron polymaltose (IPM) is the most commonly used parenteral iron therapy for iron deficiency anaemia. Intravenous IPM is prepared by diluting IPM injection with 0.9% sodium chloride. The stability of diluted IPM is not known beyond 24 hours. Therefore, diluted IPM must be prepared on a daily basis, resulting in substantial limitations and problems.

Aim: To determine the stability of diluted IPM in polyvinyl chloride (PVC) infusion bags at different storage conditions for up to 28 days.

Method: IPM 2 mg/mL samples were prepared in 0.9% sodium chloride 500 mL PVC infusion bags. Infusion bags were kept in light protective bags or exposed to artificial light and stored at either 4 °C or 25 °C for up to 28 days. Aliquots were withdrawn immediately after preparation (Day 0) or after Days 1, 2, 3, 6, 7, 14, 21 and 28. Samples were analysed by high-performance size-exclusion chromatography to measure the changes in concentration or molecular weight profi le of IPM before and after storage. Samples were also investigated for particle size distribution by dynamic light scattering and for the free iron content by ion chromatography.

Results: Diluted IPM remained physicochemically stable (with or without light protection) at room temperature or in the refrigerator for at least 28 days.

Conclusion:

Aseptically prepared IPM 2 mg/mL intravenous solution in 0.9% sodium chloride PVC infusion bags was stable for 28 days at room temperature or in a refrigerator.