Comprehensive physicochemical analysis of ferric carboxymaltose products marketed in India

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dc.contributor.authorDubey, Ven_US
dc.contributor.authorJagtap, MBen_US
dc.contributor.authorSavla, Hen_US
dc.contributor.authorShinde, UAen_US
dc.contributor.authorAmbre, PK.en_US
dc.date.accessioned2025-08-13T11:44:21Z
dc.date.available2025-08-13T11:44:21Z
dc.date.issued2025-07
dc.description.abstractBackground: 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.en_US
dc.identifier.affiliationsDepartment of Pharmaceutical Chemistry, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutical Chemistry, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutical Chemistry, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra, Indiaen_US
dc.identifier.citationDubey V, Jagtap MB, Savla H, Shinde UA, Ambre PK.. Comprehensive physicochemical analysis of ferric carboxymaltose products marketed in India . International Journal of Research in Medical Sciences. 2025 Jul; 13(7): 2801-2807en_US
dc.identifier.issn2320-6071
dc.identifier.issn2320-6012
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/254194
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber7en_US
dc.relation.volume13en_US
dc.source.urihttps://dx.doi.org/10.18203/2320-6012.ijrms20251754en_US
dc.subjectColloidal injectionen_US
dc.subjectFerric carboxymaltoseen_US
dc.subjectIron deficiency anemiaen_US
dc.subjectIron oxyhydroxide complexen_US
dc.subjectPhysicochemical parametersen_US
dc.titleComprehensive physicochemical analysis of ferric carboxymaltose products marketed in Indiaen_US
dc.typeJournal Articleen_US
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