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

doi:10.22159/ajpcr.2019.v12i1.30010

Authors

Hansen Nasif Department of Biomedical Sciences, Faculty of Medicine, Andalas University, Padang, Indonesia.
Henny Lucida Department of Pharmaceutics, Faculty of Pharmacy, Andalas University, Padang, Indonesia.
Yanwirasti Yanwirasti Department of Anatomy, Faculty of Medicine, Andalas University, Padang, Indonesia.
Yufri Aldi Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Andalas University, Padang, Indonesia.
Yori Yuliandra Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Andalas University, Padang, Indonesia.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i1.30010

Keywords:

Annexin A1, Branded generic, Generic, Innovator drug, Methylprednisolone

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.

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