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

Journal Article · · Nanomaterials
DOI:https://doi.org/10.3390/nano8010025· OSTI ID:1628503
 [1];  [2];  [2];  [3];  [3];  [4];  [4];  [5];  [6];  [7];  [8]
  1. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Generic Drugs. Office of Research and Standards; DOE/OSTI
  2. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Translational Sciences. Office of Clinical Pharmacology. Division of Applied Regulatory Science
  3. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Devices and Radiological Health. Office of Science and Engineering Labs.
  4. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). National Center for Toxicological Research
  5. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Pharmaceutical Quality. Office of Testing and Research. Division of Pharmaceutical Analysis
  6. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Pharmaceutical Quality. Office of Testing and Research. Division of Pharmaceutical Analysis
  7. Purdue Univ., West Lafayette, IN (United States). Bindley Bioscience Center
  8. U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Generic Drugs. Office of Research and Standards
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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.

Research Organization:
Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
Sponsoring Organization:
USDOE Office of Science (SC)
Grant/Contract Number:
SC0014664
OSTI ID:
1628503
Journal Information:
Nanomaterials, Journal Name: Nanomaterials Journal Issue: 1 Vol. 8; ISSN 2079-4991; ISSN NANOKO
Publisher:
MDPICopyright Statement
Country of Publication:
United States
Language:
English

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60 APPLIED LIFE SCIENCES
Ferrlecit
Materials Science
Science & Technology - Other Topics
bioequivalence
generic drugs
parenteral iron
sodium ferric gluconate complex