Pharmaceutical Development and Safety Evaluation of a GMP-Grade Fucoidan for Molecular Diagnosis of Cardiovascular Diseases.

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ID: 71353
2019
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Abstract
The adhesion molecule P-selectin is present on the cell surface of both activated endothelium and activated platelets. The present study describes the pharmaceutical development, safety evaluation, and preclinical efficacy of a micro-dosed radiotracer. The macromolecular nanoscale assembly consisted of a natural compound made of a sulfated fucose-rich polysaccharides (fucoidan) and a radionuclide (technetium-99m) for the detection of -selectin expression in cardiovascular diseases. After extraction and fractionation from brown seaweeds, the good manufacturing practice (GMP) production of a low molecular weight (LMW) fucoidan of 7 kDa was achieved and full physicochemical characterization was performed. The regulatory toxicology study in rats of the GMP batch of LMW fucoidan revealed no adverse effects up to 400 μg/kg (×500 higher than the expected human dose) and pseudoallergy was not seen as well. In a myocardial ischemia-reperfusion model in rats, the GMP-grade LMW fucoidan labeled with technetium-99m detected -selectin upregulation in vivo. The present study supports the potential of using Tc-fucoidan as an imaging agent to detect activated endothelium in humans.
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chauvierre2019pharmaceuticalmarine Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Chauvierre, Cédric;Aid-Launais, Rachida;Aerts, Joël;Chaubet, Frédéric;Maire, Murielle;Chollet, Lucas;Rolland, Lydia;Bonafé, Roberta;Rossi, Silvia;Bussi, Simona;Cabella, Claudia;Dézsi, Laszlo;Fülöp, Tamas;Szebeni, Janos;Chahid, Youssef;Zheng, Kang H;Stroes, Erik S G;Le Guludec, Dominique;Rouzet, François;Letourneur, Didier;
Journal Marine drugs
Year 2019
DOI
E699
URL
Keywords
molecular diagnosis gmp-grade fucoidan regulatory toxicology scintigraphy

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