Low molecular weight heparins: Structural differentiation by spectroscopic and multivariate approaches

Various branded low molecular weight heparins (LMWHs) have been used for the treatment and prevention of thrombotic for over 20 years. With the introduction of generic LMWHs and the recent events involving heparin contamination, a great deal of effort is being expended in investigating ways of monitoring and regulating this class of complex drugs. In this paper, we present the characterization of different forms of LMWHs, as well as the comparison of 5 enoxaparin copies from different manufactures. The data suggests that, while some of these drugs are structurally comparable, specific analytical methods as well as biological and pharmacological tests may be used to address their similarity, quality and potential interchangeability. The proposed approach may also be useful in comparing biosimilar and branded LMWHs. (C) 2011 Elsevier Ltd. All rights reserved.