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Updated: Jan 1, 2026
04:40
Dynamic Light Scattering Analysis for the Determination of the Particle Size of Iron-Carbohydrate Complexes
Published on: July 7, 2023
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Iron polymaltose complexes: Could we spot physicochemical differences in medicines sharing the same active
Tiziana Di Francesco1, Léadie Delafontaine1, Erik Philipp2
1School of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Geneva, Switzerland.
Summary
Iron polymaltose complex (IPC) and its generics (IPCSs) show significant physicochemical differences. Therapeutic equivalence is unproven, necessitating new guidelines for these nanomedicines.
Area of Science:
- Pharmaceutical Sciences
- Nanomedicine
- Drug Characterization
Background:
- Oral iron therapy, including iron(III) preparations like iron polymaltose complex (IPC), aims to treat iron deficiency and anemia.
- Concerns regarding side effects of traditional iron(II) salts have led to the adoption of iron(III) alternatives.
- Current evidence on the efficacy and therapeutic equivalence of IPC and its follow-on versions (IPCSs) is inconsistent.
Purpose of the Study:
- To conduct a pioneering evaluation of the physicochemical properties of iron polymaltose complex (IPC) and iron polymaltose complex similars (IPCSs).
- To identify potential deviations among commercially available products that claim to contain the same active pharmaceutical ingredient.
- To assess the nanomedicine characteristics of these iron preparations.
Main Methods:
- Comparative analysis of physicochemical properties of originator IPC and IPCS products.
- Evaluation of size, size distribution, stability, and degradation kinetics.
- Assessment of nanomedicine characteristics for both IPC and IPCSs.
Main Results:
- Significant differences were observed in the size and size distribution between IPC and IPCSs.
- Variations in stability and degradation kinetics were identified among the evaluated products.
- The physicochemical deviations suggest potential differences in nanomedicine behavior.
Conclusions:
- Therapeutic equivalence between iron polymaltose complex (IPC) and iron polymaltose complex similars (IPCSs) is not demonstrated by this physicochemical evaluation.
- New regulatory guidelines are required to assess the interchangeability of these nanomedicines.
- Further research is needed to ensure the consistent quality and clinical performance of iron-based nanomedicines.
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