Iron is not just iron

The development of injectable Iron for piglets

Traditional Iron Dextran
Injectable iron dextran has been used to treat piglets since the 1950’s.1 The first generation had some disadvantages and they were produced with organic solvents. It was difficult-to-produce with more than 10% elemental iron. There were some side effects and risk of tissue staining.2

Gleptoferron
Injectable iron based on the Gleptoferron formulation was developed in 1967. Gleptoferron was produced using organic solvents and cyanide and, therefore, subject to the presence of residual solvents and cyanide impurities in the product. This method of synthesis has only been approved for veterinary use2.

Modern Iron Dextran
Pharmacosmos’ Uniferon® was approved by the European Medicine Agency in 20083 and the FDA in 20114. Uniferon® is an iron hydrogenated dextran produced without any organic solvents or cyanide. Uniferon® is produced in a manufacturing facility approved for human drugs manufactured following the same drug standards as our human drug products. Uniferon® is a highly stable 200mg/ml iron dextran complex that is completely absorbed, assimilated and converted into blood haemoglobin by the piglet5.  Since launch, no reports of staining have been reported in the hundreds of millions of piglets injected.

    Quality matters - Iron is not just iron

    The biological activity of nanoparticles depends on particle content and particle properties.6 Differences in any of these parameters can have significant impact on the efficacy and safety profile of the injectable iron product.6 Even products with the same generic name can differ in their safety and efficacy depending on the manufacturing methods, facilities and controls utilized.7

      Uniferon vs. Gleptoferron

      Uniferon – an improved iron hydrogenated dextran

      Uniferon® is a modern iron hydrogenated dextran product with a natural formula without use of any organic solvents or cyanide, and approved in Europe, Asia and the U.S.

      1. References: 1: Martin, L.E., et al. “The pharmacology of an Iron-dextran intramuscular haematinic”. British Journal of Pharmacology and Chemotherapy, 1955; 10:375–382. 2: United States Patent Office 3,536,696. Patented Oct. 27, 1970: Ferric hydroxide dextran and dextrin heptonic acids. 3: Procedure No. DK/V/0114/01/MR. 4: Gaddy, H.J. et al. “A review of recent supplemental iron industry practices and current usage of Uniferon® (iron dextran complex injection, 200 mg/ml) in piglets”. In: Proc. 43rd AASV Cong., March 2012. 5: Periodic Safety Update Report (PSUR); MRP renewal. Product: Veterinary iron dextran, solution for injection; Period of reporting: 27.10.2010 – 27.02.2015. 6: Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator product EMA/CHMP/ SWP/620008/2012. 7: Crommelin, Daan J.A. et al. ”Non-biological complex drugs – the science and the regulatory landscape”, Springer 2015