Background: Ferric carboxymaltose (FCM) formulation consists of iron-carbohydrate
nanoparticles where iron-oxyhydroxide as a core is covered by a carbohydrate shell. The present
work provides an improved synthesis process of FCM as an intravenous iron, active pharmaceutical
Methods: Water-soluble FCM complex was prepared from the reaction of ferric hydroxide precipitation
with an aqueous solution of oxidized maltodextrin (MD) at optimum temperature and pH
conditions. A systematic approach was followed to obtain the optimal weight ratio of the maltodextrin/
ferric chloride for FCM synthesis process with suitable-sized nanoparticles. Physical characterization
of newly synthesized ferric carboxymaltose (FCM-NP) was performed to establish its equivalency
with the reference product (Ferinject).
Results: The size distribution of the whole nanoparticles determined by dynamic light scattering
(DLS) was in the range of 15-40 nm with an average particle size of 26 ± 6.6 and 25.8 ± 4.9 for
FCM-NP and Ferinject, respectively. X-ray diffraction (XRD) results of FCM-NP and Ferinject indicated
the Akaganeite structure of iron-oxyhydroxide. The iron content of particles (cores) measured
by Atomic absorption spectroscopy (AAS) was almost equal for the two formulations. The
Fourier transform infrared (FTIR) spectra of Ferinject and FCM-NP were approximately similar.
Conclusion: Various analytical methods, including FTIR spectroscopy, XRD analysis, DLS technique,
TEM, and AAS were employed. It was observed that the specifications of FCM-NP obtained
by these analyses were almost identical to those of Ferinject. Accordingly, the two formulations
were considered comparable.