Publication:

Comprehensive physicochemical analysis of ferric carboxymaltose products marketed in India

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.