Evaluation of the antiplatelet effect of generic ticagrelor 90 mg (ticaspan ® ) alone and in combination with aspirin 75 mg as compared to ticagrelor (innovator): An in vitro study.

Abstract

Objective: To evaluate an in vitro antiplatelet effect of generic ticagrelor 90 mg (ticaspan) alone and in combination with aspirin 75 mg as compared to the innovator formulation of ticagrelor alone and in combination with aspirin among healthy Indian volunteers.

Methods: 18 volunteers were enrolled and platelet viability was tested using lactate dehydrogenase (LDH) assay in six of 18 volunteers. In 12 volunteers, maximum platelet aggregation (MPA) and percentage inhibition of platelet aggregation (PI) were assessed using a platelet aggregometer in six study groups.

Results: There was no significant increase in LDH levels when platelets were incubated with an innovator or generic drug alone and in combination with aspirin as compared to the dimethyl sulfoxide [DMSO] group. All five study groups showed a significant reduction in the MPA values compared to the DMSO group ( P < 0.01). The extent of decrease in MPA observed with the generic drug was not significantly different from the innovator drug ( P = 0.325). Similarly, the MPA observed with the two combination groups did not differ from each other ( P = 1.000), but it was significantly different from the MPA observed with aspirin ( P = 0.039, each). The PI of platelet aggregation was significantly more in four study groups [generic drug alone; innovator alone; generic drug + aspirin; and innovator drug + aspirin] ( P < 0.01) as compared to the aspirin group.

Conclusion: The generic ticagrelor and its combination with aspirin demonstrated an antiplatelet effect equivalent to the innovator drug and its combination with aspirin.