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Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats

Relative biodistribution of FDA-approved innovator and generic sodium ferric gluconate (SFG) drug products was investigated to identify differences in tissue distribution of iron after intravenous dosing to rats. Three equal cohorts of 42 male Sprague-Dawley rats were created with each cohort receiv...

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Autores principales: Beekman, Christopher R., Matta, Murali K., Thomas, Christopher D., Mohammad, Adil, Stewart, Sharron, Xu, Lin, Chockalingam, Ashok, Shea, Katherine, Sun, Dajun, Jiang, Wenlei, Patel, Vikram, Rouse, Rodney
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791097/
https://www.ncbi.nlm.nih.gov/pubmed/29283393
http://dx.doi.org/10.3390/nano8010010
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author Beekman, Christopher R.
Matta, Murali K.
Thomas, Christopher D.
Mohammad, Adil
Stewart, Sharron
Xu, Lin
Chockalingam, Ashok
Shea, Katherine
Sun, Dajun
Jiang, Wenlei
Patel, Vikram
Rouse, Rodney
author_facet Beekman, Christopher R.
Matta, Murali K.
Thomas, Christopher D.
Mohammad, Adil
Stewart, Sharron
Xu, Lin
Chockalingam, Ashok
Shea, Katherine
Sun, Dajun
Jiang, Wenlei
Patel, Vikram
Rouse, Rodney
author_sort Beekman, Christopher R.
collection PubMed
description Relative biodistribution of FDA-approved innovator and generic sodium ferric gluconate (SFG) drug products was investigated to identify differences in tissue distribution of iron after intravenous dosing to rats. Three equal cohorts of 42 male Sprague-Dawley rats were created with each cohort receiving one of three treatments: (1) the innovator SFG product dosed intravenously at a concentration of 40 mg/kg; (2) the generic SFG product dosed intravenously at a concentration of 40 mg/kg; (3) saline dosed intravenously at equivalent volume to SFG products. Sampling time points were 15 min, 1 h, 8 h, 1 week, two weeks, four weeks, and six weeks post-treatment. Six rats from each group were sacrificed at each time point. Serum, femoral bone marrow, lungs, brain, heart, kidneys, liver, and spleen were harvested and evaluated for total iron concentration by ICP-MS. The ICP-MS analytical method was validated with linearity, range, accuracy, and precision. Results were determined for mean iron concentrations (µg/g) and mean total iron (whole tissue) content (µg/tissue) for each tissue of all groups at each time point. A percent of total distribution to each tissue was calculated for both products. At any given time point, the overall percent iron concentration distribution did not vary between the two SFG drugs by more than 7% in any tissue. Overall, this study demonstrated similar tissue biodistribution for the two SFG products in the examined tissues.
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spelling pubmed-57910972018-02-05 Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats Beekman, Christopher R. Matta, Murali K. Thomas, Christopher D. Mohammad, Adil Stewart, Sharron Xu, Lin Chockalingam, Ashok Shea, Katherine Sun, Dajun Jiang, Wenlei Patel, Vikram Rouse, Rodney Nanomaterials (Basel) Article Relative biodistribution of FDA-approved innovator and generic sodium ferric gluconate (SFG) drug products was investigated to identify differences in tissue distribution of iron after intravenous dosing to rats. Three equal cohorts of 42 male Sprague-Dawley rats were created with each cohort receiving one of three treatments: (1) the innovator SFG product dosed intravenously at a concentration of 40 mg/kg; (2) the generic SFG product dosed intravenously at a concentration of 40 mg/kg; (3) saline dosed intravenously at equivalent volume to SFG products. Sampling time points were 15 min, 1 h, 8 h, 1 week, two weeks, four weeks, and six weeks post-treatment. Six rats from each group were sacrificed at each time point. Serum, femoral bone marrow, lungs, brain, heart, kidneys, liver, and spleen were harvested and evaluated for total iron concentration by ICP-MS. The ICP-MS analytical method was validated with linearity, range, accuracy, and precision. Results were determined for mean iron concentrations (µg/g) and mean total iron (whole tissue) content (µg/tissue) for each tissue of all groups at each time point. A percent of total distribution to each tissue was calculated for both products. At any given time point, the overall percent iron concentration distribution did not vary between the two SFG drugs by more than 7% in any tissue. Overall, this study demonstrated similar tissue biodistribution for the two SFG products in the examined tissues. MDPI 2017-12-28 /pmc/articles/PMC5791097/ /pubmed/29283393 http://dx.doi.org/10.3390/nano8010010 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Beekman, Christopher R.
Matta, Murali K.
Thomas, Christopher D.
Mohammad, Adil
Stewart, Sharron
Xu, Lin
Chockalingam, Ashok
Shea, Katherine
Sun, Dajun
Jiang, Wenlei
Patel, Vikram
Rouse, Rodney
Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
title Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
title_full Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
title_fullStr Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
title_full_unstemmed Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
title_short Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
title_sort comparative evaluation of u.s. brand and generic intravenous sodium ferric gluconate complex in sucrose injection: biodistribution after intravenous dosing in rats
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791097/
https://www.ncbi.nlm.nih.gov/pubmed/29283393
http://dx.doi.org/10.3390/nano8010010
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