Short-term stability of a new generic sodium ferric gluconate in complex with sucrose

Abstract

Background:

Sodium ferric gluconate in complex (SFG) is used to treat iron deficiency anemia in patients aged ≥6 years undergoing chronic hemodialysis and receiving supplemental epoetin therapy. Both the branded product (Ferrlecit, branded SFG) and a new generic version of sodium ferric gluconate in complex (Nulecit; generic SFG) are provided in 5 mL vials. SFG may be administered by slow intravenous (IV) injection of the undiluted product or by 1 h IV infusion after dilution in 100 mL 0.9% sodium chloride. This study evaluated the short-term stability of undiluted and diluted generic SFG at room temperature and under refrigeration.

Methods:

Samples of generic SFG undiluted in 10 mL syringes or diluted in IV infusion bags containing 0.9% sodium chloride solution were stored at room temperature or under refrigerated conditions (2–8°C). Samples at room temperature were stored for ≤48 h if undiluted and for ≤24 h if diluted. All refrigerated samples were stored for ≤7 days. Parameters evaluated were elemental iron (Fe) concentration and SFG apparent molecular weight. All tests were performed on two lots of the generic product.

Results:

Fe concentrations were identical in both lots and did not vary substantially over time under different conditions of storage or dilution. SFG apparent molecular weight varied across all samples from 306,000 to 354,000 Daltons, well within the range of 289,000 to 440,000 Daltons specified as the molecular weight in the FDA-approved prescribing information.

Conclusion:

Iron content and SFG apparent molecular weight were stable under all experimental conditions. Undiluted generic SFG was stable for ≥2 days at room temperature and ≥7 days under refrigerated conditions, and generic SFG diluted in IV infusion bags containing 0.9% sodium chloride solution was stable for ≥1 day at room temperature and ≥7 days under refrigerated conditions.

Key words::

• Ferric gluconate
• Pharmaceutical technology
• Stability

Transparency

Declaration of funding

This study was sponsored by Watson Laboratories, Inc. Editorial assistance in the preparation of the manuscript was provided by Scientific Connexions and funded by Watson Pharma, Inc.

Declaration of financial/other relationships

D.B. has disclosed that he is a consultant for Watson, is on their speaker’s bureau and has received research funding from them. He has also disclosed that he is a consultant and on the speaker’s bureau for Amgen and Eisai, and is a consultant for Genentech and Hospira.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

D.B. contributed to the analysis and interpretation of the study results, wrote the manuscript, and reviewed and approved the final draft. Frontage contributed to the study design and data collection and reviewed the manuscript for scientific accuracy. Watson Laboratories, Inc. reviewed the manuscript for scientific accuracy and completeness. Roland Tacke, PhD, and Marsha Hall of Scientific Connexions, Newtown, PA, provided medical writing and editorial services with funding from Watson Pharma, Inc.

Notes

*Ferrlecit is a registered trademark of A. Nattermann & Cie. GmbH.

†Nulecit is a registered trademark of Watson Pharmaceuticals, Inc.