Pharmacodynamics effect of methylprednisolone tablets on the serum concentration of annexin A1: in vivo comparative study between generic and innovator drug

HANSEN NASIF, HENNY LUCIDA , YANWIRASTI YANWIRASTI, YUFRI ALDI, YORI YULIANDRA

Abstract

Objective: The aims of this study were to investigate the comparative pharmacodynamics effect of methylprednisolone (MP) innovator, MP branded generic, and MP generic products to the serum concentration of annexin A1 (AnxA1).
Methods: It was conducted by two-way crossover design in male rabbits. AnxA1 was measured at 0, 0.5, 1, 2, 3, 5, 7, and 9 h after the administration of the drugs. The peak concentration (Cmax), the time at which the peak concentration was achieved (Tmax), and the area under the plasma concentration-time curve (AUC) were also determined.
Results: The highest concentration and widest AUC of AnxA1 were obtained in MP innovator drug. MP innovator and branded generic reaches the peak time (Tmax) at the third 3rd h, while the MP generic reaches the peak time at the 5th h. The results showed that there was no significant difference in the serum concentration of AnxA1 between MP tablets after analyzed with a one-way analysis of variance.
Conclusion: It could be concluded that the innovator drug of MP tablet gave the same effect on the serum concentration of AnxA1 than its generic counterparts, but an onset of action MP innovator and branded generic is faster than the generic product.

Full paper

Published in Asian J Pharm Clin Res 12(1), 414-417 (Jan 2019)
DOI: 10.22159/ajpcr.2019.v12i1.30010

Yori Yuliandra
Yori Yuliandra
Yori Yuliandra
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