Comprehensive physicochemical analysis of ferric carboxymaltose products marketed in India

Vaishnavi S. Dubey; Meghana B. Jagtap; Hemali M. Savla; Ujwala A. Shinde; Premlata K. Ambre

doi:10.18203/2320-6012.ijrms20251754

Authors

Vaishnavi S. Dubey Department of Pharmaceutical Chemistry, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, India https://orcid.org/0009-0001-0520-5203
Meghana B. Jagtap Department of Pharmaceutical Chemistry, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, India https://orcid.org/0009-0007-9071-8727
Hemali M. Savla Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, India https://orcid.org/0009-0000-1287-5195
Ujwala A. Shinde Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, India https://orcid.org/0000-0002-5314-4935
Premlata K. Ambre Department of Pharmaceutical Chemistry, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, India https://orcid.org/0000-0002-6228-8228

DOI:

https://doi.org/10.18203/2320-6012.ijrms20251754

Keywords:

Colloidal injection, Ferric carboxymaltose, Iron deficiency anemia, Iron oxyhydroxide complex, Physicochemical parameters

Abstract

Background: Intravenous iron therapy is essential for managing iron-deficiency anemia (IDA). Ferric carboxymaltose (FCM), a colloidal complex of ferric oxyhydroxide within a carboxymaltose shell, enhances iron delivery and supports hemoglobin synthesis. However, stability, uniformity, shelf life and efficacy challenges persist across available FCM formulations in the Indian market. The latest Indian Pharmacopoeia (IP) guidelines emphasize evaluating key physicochemical properties to ensure the quality and safety of formulations.

Methods: This first-of-its-kind study comprehensively analyzes nine marketed injectable FCM formulations including an innovator and competing brands A-H, by evaluating their physicochemical parameters with statistical validation.

Results: The evaluation highlights significant deviations in key physicochemical parameters among the brands. Brand C exceeds acceptable density and particle size limits, leading to a high PDI and increased risk of agglomeration. Brand E shows low molecular weight and carbohydrate content with an elevated PDI, indicating instability and rapid iron release. Brand F, with a higher molecular weight, exhibits elevated PD and PDI values, reflecting molecular weight diversity. Brand H surpasses acceptable density and carbohydrate content ranges, further evidenced by its high PDI.

Conclusions: FCM is widely used for IDA and pregnancy, offering rapid iron replenishment with fewer doses and cost effectiveness. This study highlights quality and safety variations among injectable FCM brands. Brand A, with strong physicochemical properties interms of osmolality, iron core size, zeta potential, particle size, iron and carbohydrate contents comparable to the innovator, stands out as a reliable option for intravenous iron supplementation, ensuring efficacy and patient safety.

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