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Ovine Mucosal Enoxaparin Exhibit Comparable Pharmacokinetic Profiles to Porcine Mucosal Enoxaparin
Author(s) -
Rangnekar Varun,
Kouta Ahmed,
Jeske Walter,
Yao Yiming,
Hoppensteadt Debra,
Niverthi Manoj,
Duff Rick,
Fareed Jawed
Publication year - 2019
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.2019.33.1_supplement.515.12
Subject(s) - pharmacokinetics , cmax , low molecular weight heparin , pharmacology , heparin , chemistry , volume of distribution , anticoagulant , medicine
Background Low Molecular Weight Heparins (LMWH) such as Enoxaparin are currently derived from porcine mucosal heparin (PMH), the same depolymerization methods can be used to obtain enoxaparin from unfractionated heparin from other sources. The purpose of this study is to compare the pharmacokinetics of ovine mucosal enoxaparin (OME) with that of porcine mucosal enoxaparin (PME). Materials and Methods Branded Enoxaparin (Lovenox, Sanofi‐Aventis, Bridgewater, NJ) and three batches of OME (Suzhou Ronnsi Pharma, Suzhou, China) were used. Following anesthesia, a baseline blood sample was collected from primates (Macaca mulatta; n=4). LMWH was administered subcutaneously (SC) at a dose of 1 mg/kg. Additional blood samples were collected at various times (2,4,6 hours). Anti‐Xa and anti‐thrombin assays were used to calculate pharmacokinetic parameters. Tissue factor pathway inhibitor antigen levels were also measured using an ELISA method. Results In the samples collected at 2, 4, and 6 hours, comparable levels of branded PME and the three batches of OME were observed using both anti‐Xa and anti‐thrombin assays. The pharmacokinetic parameters such as biologic half‐life, Cmax, volume of distribution, and clearance were comparable for both the ovine and porcine enoxaparin. Tissue Factor Pathway Inhibitor levels returned to baseline levels by 6 hours in OME, but remained slightly elevated with PME. Discussion At a 1 mg/kg SC dosage, three OME preparations produced comparable anti‐Xa and anti‐IIa effects which were similar to the ones observed with PME. The PK parameters calculated based on this data were also comparable for both groups. It is concluded that the SC pharmacokinetics of the three batches of OME were not only comparable between batches, but were also similar to the branded product. Support or Funding Information None. This abstract is from the Experimental Biology 2019 Meeting. There is no full text article associated with this abstract published in The FASEB Journal .