Iron has an important role in certain cellular metabolic pathways and is also vital for heme synthesis and in the transport of oxygen. There are multiple underlying conditions that could lead to iron deficiency, including gastrointestinal bleeding, inflammatory bowel disease, cancer, chronic kidney disease or more. Iron deficiency is characterized by extreme fatigue, pale skin, weakness or even headaches and light headedness.
The Network for Advancement of Transfusion Alternatives recommends the treatment of iron deficiency prior to use of erythropoiesis-stimulating agents (ESAs) among patients with anemia. There is a need for corrective strategies for iron deficiency, for general health and also in preparation for surgery or to support care for people with underlying health conditions.
There are multiple iron formulations that are used for intravenous iron injections but when the adverse events for iron sucrose, ferric gluconate, and iron dextrans was assessed using pharmacovigilance databases from US Food and Drug Administration (FDA) and World Health Organization (WHO) between the years 1997 and 2009 , iron sucrose was shown to have lower adverse events.
Leveraging Vast Experience and Expertise to Support Efficient Iron Sucrose Bioequivalence Studies
To meet the demands of the healthcare industry, Navitas life sciences has developed robust methodologies for evaluating Iron-Carbohydrate preparations, leveraging our extensive knowledge about the complexities in iron sucrose preparations and the availability of the right resources. Our ability to find unique solutions to addresses customer expectations in a regulated bioanalysis environment aid us in bringing your iron preparation to the market faster.
We took the time to interview K V Lakshminarayana, General Manager-Bioanalytical, Navitas Life Sciences to understand more about the facilities and capabilities offered by Navitas Life Sciences towards supporting efficient Iron Sucrose Bioequivalence studies.
Tell us about your professional background?
I completed M. Pharm in Pharmaceutical analysis at Rajiv Gandhi University and have more than 16+ years of experience in the bioanalytical field. I have worked in varying capacities and am currently study director.
My vast experience in supporting bioequivalence studies for iron sucrose formulations has helped articulate better solutions to run efficient trials.
Share with us about your role in Navitas Life Sciences, and your support for Iron sucrose studies
I am the lab in charge of the bioanalytical lab at the Bangalore facility and a study director for Iron formulations, providing technical inputs to our team on method development, validation, and successful project execution as per regulatory requirements. Apart from that, I am responsible for conducting studies (eg. All types of elements, small molecules, large molecules, peptides, etc) at the Bangalore facility, along with study management, team management, and successful project execution within the timelines.
K V Lakshminarayana
Navitas Life Sciences
I am also associated with the allocated sponsor project feasibility assessment, sponsor and regulatory Audit, and query handling. I facilitated the inclusion of 10 LCMS instruments with supporting instruments during the year 2017-2018, aiding in expanding the capabilities at our Bangalore facility.
What is the burden of iron deficiency globally and how do you think these studies will benefit the affected?
Iron deficiency is the most common nutritional disorder in the world, affecting approximately 25% of the world`s population, and the most common cause of anemia. Anemia is a serious global public health problem that is known to particularly affect young children and pregnant women. World Health Organization (WHO) has estimated that 42% of children less than 5 years of age and 40% of pregnant women worldwide are anemic.
The use of intravenous iron sucrose preparations is a safe and effective option in the treatment of adult patients with iron deficiency anemia who lack satisfactory response to oral iron therapy. Intravenous iron sucrose is well tolerated and with a clinically manageable safety profile when using appropriate dosing and monitoring. The availability of intravenous iron sucrose would potentially improve compliance and thereby reduce morbidities from iron deficiency.
How is IV iron preferred over oral dose in people with significant iron deficiency?
Oral iron has the advantage of being simple, but it is limited by side effects, poor compliance, poor absorption, and low efficacy.
Whereas Intravenous iron is the best means of guaranteeing delivery of readily available iron to the bone marrow, but it requires greater clinical supervision. The Intravenous iron preparations vary greatly in their molecular size, their degradation kinetics (how rapidly iron is released from the complex), their bioavailability, their side-effect profiles, and maximum dose for single administration.
How has the iron formulation for IV treatment evolved over the years?
Administration of intravenous (IV) iron is pivotal in the management of anemia in patients with chronic kidney disease (CKD). As iron oxyhydroxide complex iron was first introduced for human use, but iron was toxic when administered. To overcome this problem, compounds containing iron in a core surrounded by a carbohydrate shell such as dextran, sucrose, dextrin or gluconate were introduced.
These intravenous iron preparations carried a small risk of anaphylaxis. Recently, newer intravenous iron preparations have appeared in the market including Ferumoxytol (Feraheme) and ferric carboxymaltose (Ferinject), and a much higher dose of iron can be delivered as a single administration with acceptable safety and without significant adverse effects. However, the long-term safety of the newer IV iron preparations is not yet established.
Can you provide any feedback from a client or any anecdote associated with iron sucrose studies conducted at Navitas Life Sciences?
We recently completed an intravenous bioequivalence study of Iron Sucrose Injection 20 mg/mL and successfully submitted to USFDA.
“The client felt very happy with our work, in terms of quality and data integrity and for conducting the study as per regulatory requirements within timelines.”
There are many studies in the pipeline with different formulations eg. Ferrous sulfate, ferric carboxymaltose, etc.
What are the challenges in executing the Bioequivalence studies for iron sucrose?
The major challenges are in the handling of the iron sucrose injection as it is a colloidal substance and is sticky due to which it cannot be pipetted out in appropriate volumes. There is also the risk of Iron-related interferences, as most of the consumables are made with iron moulds (egs. Polypropylene tubes, micro tips etc.,), and processing-related interferences. A clean chamber that is contamination free is required for accurately quantifying transferrin-bound iron from total iron.
What are the specific capabilities and infrastructure available for conducting iron sucrose studies?
We have an experienced and an expert bioanalytical team for handling the iron sucrose studies and have installed a clean air room for conducting such studies.
What are the advantages in choosing Navitas Life Sciences for iron sucrose studies?
The team at Navitas Life Sciences team has extensive knowledge about the complexities of iron preparations and has established robust methodologies for evaluating Iron-Carbohydrate preparations.
Navitas Life Sciences ensures stellar quality and data integrity, fulfilling customer expectations in terms of study timelines and conducting a study as per regulatory requirements to bring iron formulations to the market fast.
Total and Transferrin Bound Iron Assay for Iron Sucrose Formulations – Application in Regulated Bioanalysis
Leverage our experience and reliable bioanalytical methods expertise to quantify transferrin bound form, in addition to total iron, to support the evaluation of your bioequivalence and/or safety studies.