Abstract | INTRODUCTION:
Ferric carboxymaltose is a next-generation polynuclear iron(III)- hydroxide carbohydrate complex for intravenous iron therapy belonging to the class of so-called non-biological complex drugs. The product characteristics and therapeutic performance of non-biological complex drugs are largely defined by the manufacturing process. A follow-on product, termed herein as ferric carboxymaltose similar, is available in India. Given that non-biological complex drugs may display differences in diverse product properties not characterisable by physico-chemical methods alone. AIM: The aim is to assess the effects of this ferric carboxymaltose similar in our non-clinical model in non-anaemic healthy rats. MATERIALS AND METHODS: RESULTS: CONCLUSION: In our rat model, ferric carboxymaltose similar had a less favourable safety profile than iron sucrose originator, adversely affecting iron deposition, oxidative and nitrosative stress, inflammatory responses, with impaired liver and kidney function.
|
Authors | Jorge E Toblli, Gabriel Cao, Margarita Angerosa |
Journal | Journal of clinical and diagnostic research : JCDR
(J Clin Diagn Res)
Vol. 9
Issue 12
Pg. FF08-12
(Dec 2015)
ISSN: 2249-782X [Print] India |
PMID | 26816915
(Publication Type: Journal Article)
|