Abstract

The current study compares the anticoagulant effects of a reference heparin product, heparin Leo^® USA to a test product, heparin Hikma, Jordan. Both products are usually administered intravenous (IV) or subcutaneous (SC) and bioequivalence requirements are typically waived. Hence, it is pivotal to compare the therapeutic equivalency of the two products without jeopardizing the health of human volunteers. We have compared the anticoagulant effects of the two products in male albino rats by comparing the aPTT values 2 h following a single subcutaneous dose of either Hikma or Leo heparins. The average aPTT values for both Hikma and Leo heparins were 101.2 and 102.8 s, respectively. Further, the USP heparin assay test was performed to determine the ID₅₀ of the Hikma and Leo heparins. The average volume of heparin that caused 50% inhibition of plasmain vitro was 0.431 and 0.439 ml for Hikma and Leo heparins, respectively. There was no statistically significant difference between the two products. The study concludes that the Hikma Heparin is therapeutically equivalent to the Leo heparin. Both products could be used interchangeably.

Key words: Hikma heparin, Leo heparin, therapeutic equivalence, heparin assay test, anticoagulant effects, aPTT.