KINETICS OF GLICLAZIDE AFTER SINGLE DOSE ORAL ADMINISTRATION OF GLICLAZIDE 60 MG MODIFIED RELEASE TABLET

Diana Ioana  POP; Adriana  MARCOVICI; Monica  OROIAN; Ana-Maria  GHELDIU; Laurian  VLASE

doi:10.24193/subbchem.2020.2.15

KINETICS OF GLICLAZIDE AFTER SINGLE DOSE ORAL ADMINISTRATION OF GLICLAZIDE 60 MG MODIFIED RELEASE TABLET

Authors

Diana Ioana POP Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Iuliu Hațieganu University of Medicine and Pharmacy; Department of Clinical Pharmacology and Pharmacokinetics, Terapia SA – a Sun Pharma Company, Cluj-Napoca, Romania. Corresponding author: anamaria.gheldiu@yahoo.com.
Adriana MARCOVICI Department of Clinical Pharmacology and Pharmacokinetics, Terapia SA – a Sun Pharma Company, Cluj-Napoca, Romania. Corresponding author: anamaria.gheldiu@yahoo.com.
Monica OROIAN Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Iuliu Hațieganu University of Medicine and Pharmacy; Department of Clinical Pharmacology and Pharmacokinetics, Terapia SA – a Sun Pharma Company, Cluj-Napoca, Romania. Corresponding author: anamaria.gheldiu@yahoo.com.
Ana-Maria GHELDIU Department of Pharmaceutical Botany, Faculty of Pharmacy, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania. Email: anamaria.gheldiu@yahoo.com.
Laurian VLASE Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Iuliu Hațieganu University of Medicine and Pharmacy; Department of Clinical Pharmacology and Pharmacokinetics. Corresponding author: anamaria.gheldiu@yahoo.com. https://orcid.org/0000-0002-0664-3387

DOI:

https://doi.org/10.24193/subbchem.2020.2.15

Keywords:

gliclazide, compartmental pharmacokinetic analysis, bioequivalence clinical trials, best model

Abstract

The current study aimed to establish and describe the basic pharmacokinetics of a single dose of gliclazide 60 mg modified release formulation manufactured by Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries Limited, India. Ten mathematical models were created for analyzing the experimental data resulted from two bioequivalence studies conducted at Clinical Pharmacology and Pharmacokinetics Department of Terapia S.A. Model discrimination was done using the Akaike index value and it was observed that model number 10 (M10) is the model that best describes the gliclazide disposition. This model has two compartments (peripheral and central), mixed order absorption process (1^st and zero order kinetics) with a lag time of around 3 hrs and 1^st order kinetics of elimination. Applying this model in Phoenix software version 6.3 (Pharsight Corp., Mountain view, CA, USA) the main pharmacokinetic parameters of gliclazide were also computed.

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STUDIA UBB CHEMIA, Volume 65 (LXV), No. 2, June 2020

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Published

2020-06-30

How to Cite

POP, D. I. ., MARCOVICI, A. ., OROIAN, M. ., GHELDIU, A.-M. ., & VLASE, L. . (2020). KINETICS OF GLICLAZIDE AFTER SINGLE DOSE ORAL ADMINISTRATION OF GLICLAZIDE 60 MG MODIFIED RELEASE TABLET. Studia Universitatis Babeș-Bolyai Chemia, 65(2), 187–196. https://doi.org/10.24193/subbchem.2020.2.15