Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD

Praschberger, Monika; Cornelius, Carolin; Schitegg, Markus; Goldenberg, Hans; Scheiber-Mojdehkar, Barbara; Sturm, Brigitte

doi:10.3109/10837450.2013.852575

Cited by 9 publications

(6 citation statements)

References 30 publications

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“…In this study, the iron uptake comparison between Ferrlecit ® and the generic SFG was performed in three different human macrophage cell lines: THP-1, HL60, and U937. All three macrophage cell lines have been extensively used in research to study nanoparticle uptake [ 35 , 36 , 37 , 38 , 39 ]. For instance, the THP-1 cell line was used to study the iron uptake by comparing Venofer ® and its generic iron sucrose [ 36 ].…”

Section: Resultsmentioning

confidence: 99%

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake

Sun

Tyner

et al. 2017

Nanomaterials

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Iron deficiency anemia is a common clinical consequence for people who suffer from chronic kidney disease, especially those requiring dialysis. Intravenous (IV) iron therapy is a widely accepted safe and efficacious treatment for iron deficiency anemia. Numerous IV iron drugs have been approved by U.S. Food and Drug Administration (FDA), including a single generic product, sodium ferric gluconate complex in sucrose. In this study, we compared the cellular iron uptake profiles of the brand (Ferrlecit®) and generic sodium ferric gluconate (SFG) products. We used a colorimetric assay to examine the amount of iron uptake by three human macrophage cell lines. This is the first published study to provide a parallel evaluation of the cellular uptake of a brand and a generic IV iron drug in a mononuclear phagocyte system. The results showed no difference in iron uptake across all cell lines, tested doses, and time points. The matching iron uptake profiles of Ferrlecit® and its generic product support the FDA’s present position detailed in the draft guidance on development of SFG complex products that bioequivalence can be based on qualitative (Q1) and quantitative (Q2) formulation sameness, similar physiochemical characterization, and pharmacokinetic bioequivalence studies.

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Section: Resultsmentioning

confidence: 99%

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake

Sun

Tyner

et al. 2017

Nanomaterials

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“…IS-Claris (Claris Lifesciences Ltd., Ahmedabad, India) showed comparable physicochemical properties as the brand product [ 32 , 33 ]. When ISS products showed different Fe(III)/Fe(II) reduction potential from the brand product, differences in cellular uptake (e.g., iron sucrose AZAD) [ 34 ], oxidative stress and inflammatory response in rats (e.g., six ISSs in Asia) [ 35 ], hemodynamic and tissue responses in rats (e.g., Generis) [ 36 , 37 ], and clinical responses (e.g., Ferex) [ 29 ] were observed. In the Ferex case, there was an increase in incidences of injection site reactions and phlebitis in postpartum and gynecologic operative patients [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

et al. 2018

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The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit) and generic sodium ferric gluconate (SFG) in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC) and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS). In addition, brand and generic SFG complex products showed comparable molecular weight distributions when determined by gel permeation chromatography (GPC). The observed minor differences between brand and generic SFG, such as sedimentation coefficient, do not impact their biological activities in separate studies of in vitro cellular uptake and rat biodistribution. Coupled with the ongoing clinical study comparing the labile iron level in healthy volunteers, the FDA-funded post-market studies intended to illustrate comprehensive surveillance efforts ensuring safety and efficacy profiles of generic SFG complex in sucrose injection, and also to shed new light on the approval standards on generic parenteral iron colloidal products.

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“…There are a noticeable number of animal and clinical studies demonstrating the safety and effectiveness of intravenous iron sucrose for the treatment of iron de ciency. [17], [24], [25] In this regard, to correct the existing misinterpretations and to minimise con icts between in vitro and in vivo reports, efforts should be made to utilise in vitro models that to a great extent mimic the physiological conditions, represent cell-cell interactions, and are providing high sensitivity and accuracy when used to investigate nanoparticles behaviour and stability. [7], [26] To determine the impact of shear stress on cellular uptake of iron sucrose nanoparticles by HUVECs, Perl's Prussian blue staining method [27] was implemented for both dynamic and static culture condition.…”

Section: Discussionmentioning

confidence: 99%

Endothelium Response to Iron Sucrose Nanoparticles in Static Versus Dynamic Culture Model

Nikravesh

Diener

Chortarea

et al. 2021

Preprint

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Nanomedicines are promising therapeutic compounds allowing the development of new treatment approaches. However, important factors affecting the behavior of nanoparticles in vivo cannot be simulated in conventional static models. Dynamic cell cultures, where cells are cultivated in the presence of shear stress, have the potential to bridge this gap by mimicking critical features of physiological conditions. Iron-carbohydrate nanoparticles are a dominant treatment for iron deficiency unresponsive to oral iron supplements. Compared to the data available from clinical studies, little is known about the interaction of these particles with endothelial cells. Our approach implements and compares a microchannel-based dynamic human endothelium model to the static culture to explore potential differences in cells response after exposure to iron nanoparticles. Differences in cellular uptake are observable using Prussian blue assay. There is a noticeable increase on VCAM-1 and ICAM-1 gene expression on endothelial cells activated by inflammatory responses, in cells exposed to nanoparticles under static condition. Results show that cytotoxicity caused by iron particles is significantly lower under dynamic condition compared to static cultures. We demonstrate that inclusion of dynamic flow and biological fluids are positive steps towards nanoparticle evaluation in a physiologically relevant in vitro model.

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Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD

Abstract: ISA shows identical physico-chemical features and identical bioavailability in vitro. This study is a profound basis for future clinical tests with generic iron sucrose compounds.

Cited by 9 publications

References 30 publications

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

Endothelium Response to Iron Sucrose Nanoparticles in Static Versus Dynamic Culture Model

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