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Updated: May 11, 2026
04:40
Dynamic Light Scattering Analysis for the Determination of the Particle Size of Iron-Carbohydrate Complexes
Published on: July 7, 2023
Physicochemical and structural characterization of iron-sucrose formulations: a comparative study
Bhavesh S Barot1, Punit B Parejiya, Dharmik M Mehta
1Department of Pharmaceutics, K.B. Institute of Pharmaceutical Education and Research , Kadi Sarva Vishwavidyalaya, Gandhinagar , India.
Pharmaceutical Development and Technology
|May 25, 2013
Summary
This study characterized iron-sucrose (IS-Claris), a new intravenous iron formulation, comparing it to Venofer®. Physicochemical analyses confirmed IS-Claris is comparable to the reference product, ensuring safety and efficacy for iron deficiency anemia treatment.
Area of Science:
- Pharmaceutical Sciences
- Nanotechnology
- Analytical Chemistry
Background:
- Intravenous iron formulations are crucial for treating iron deficiency anemia (IDA) in chronic kidney disease (CKD) and other conditions.
- Iron preparations involve iron-carbohydrate nanoparticles with an iron-oxyhydroxide core and carbohydrate shell.
- Thorough physicochemical and pharmacological characterization is essential for safety and efficacy.
Purpose of the Study:
- To conduct a comprehensive physicochemical characterization of a new generic iron-sucrose preparation (IS-Claris).
- To establish the equivalency of IS-Claris with the reference product, Venofer®.
- To support the safety and efficacy of IS-Claris for clinical use.
Main Methods:
- Gel permeation chromatography (GPC)
- Mass spectroscopy (MALDI-TOF)
- Absorption spectroscopy
- X-ray diffraction analysis (XRD)
- Nuclear magnetic resonance (NMR) spectroscopy (proton and 13C)
- Fourier transform infrared (FTIR) spectroscopy
- Thermal gravimetric analysis (TGA)
Main Results:
- IS-Claris demonstrated physicochemical properties comparable to Venofer® across all tested analytical techniques.
- The characterization confirmed the structural integrity and nanoparticle nature of the iron-sucrose complex.
- No significant differences were observed between IS-Claris and the reference product.
Conclusions:
- IS-Claris is a comparable generic alternative to Venofer® for intravenous iron therapy.
- The detailed physicochemical characterization supports the established safety and efficacy profile of IS-Claris.
- This study validates the use of IS-Claris in managing iron deficiency anemia.
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