Back to Search Start Over

Structural Characterization of the Low-Molecular-Weight Heparin Dalteparin by Combining Different Analytical Strategies

Authors :
Antonella Bisio
Elena Urso
Marco Guerrini
Pauline de Wit
Giangiacomo Torri
Annamaria Naggi
Source :
Molecules, Vol 22, Iss 7, p 1051 (2017)
Publication Year :
2017
Publisher :
MDPI AG, 2017.

Abstract

A number of low molecular weight heparin (LMWH) products are available for clinical use and although all share a similar mechanism of action, they are classified as distinct drugs because of the different depolymerisation processes of the native heparin resulting in substantial pharmacokinetic and pharmacodynamics differences. While enoxaparin has been extensively investigated, little information is available regarding the LMWH dalteparin. The present study is focused on the detailed structural characterization of Fragmin® by LC-MS and NMR applied both to the whole drug and to its enzymatic products. For a more in-depth approach, size homogeneous octasaccharide and decasaccharide components together with their fractions endowed with high or no affinity toward antithrombin were also isolated and their structural profiles characterized. The combination of different analytical strategies here described represents a useful tool for the assessment of batch-to-batch structural variability and for comparative evaluation of structural features of biosimilar products.

Details

Language :
English
ISSN :
14203049
Volume :
22
Issue :
7
Database :
Directory of Open Access Journals
Journal :
Molecules
Publication Type :
Academic Journal
Accession number :
edsdoj.468114ffde64d0b9883bbdf6e265449
Document Type :
article
Full Text :
https://doi.org/10.3390/molecules22071051