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Bioequivalence of Two Brands of Metformin 850 mg Coated Tablets in 12 Healthy Algerian Volunteers: A Pilot Study




Author(s)

Mansouri, K., Aissa, L., Bounab, A. H., Hadjaz, I. M., Nekhoul, K., Djellouli, S., Kheddouci, L., Cherait, I., Behloul, S. and Mansouri, M. B.

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DOI:10.17265/2328-2150/2017.10.005

A randomized, two-way, crossover study was conducted in 12 fasting, healthy, algerian volunteers to compare the

bioavailability of two brands of metformin hydrochloride 850 mg coated tablets. The present study aimed to appreciate the bioequivalence of the generic product and to evaluate the intra-subject variability of this active substance in the Algerian population. The test brand was compared to Glucophage (Merck UK) as the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals products from 03 to 04, 2011, in joint venture with specialized medical hospital center of El Hadi Flici, Algiers, Algeria. The drug was administered with 200 mL of water after a 10 h overnight fasting on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 12 h. A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric (LC-MS/MS) method has been developed and validated for estimation of metformin in human plasma using propranolol as internal standard. The analytes were extracted from plasma by using the protein precipitation extraction technique. The assay was found to be linear over the range of 50-3000 ng/mL with a lower limit of quantitation of 50 ng/mL. Various pharmacokinetic parameters including AUC_0-t, AUC_0-∞, C_max, T_max, and T_1/2 were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC_0-t, AUC_0-∞ and C_max were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval ([91.62 %, 115.66%] for AUC_0-t, [92.07 %, 115.53 %] for AUC_0-∞; [94.58%, 119.58 %] for C_max) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Metformin hydrochloride test is bioequivalent to Glucophage.

Metformin hydrochloride, bioequivalence, LC-MS/MS, pharmacokinetics.

Mansouri, K., et al. 2017. “Bioequivalence of Two Brands of Metformin 850 mg Coated Tablets in 12 Healthy Algerian Volunteers: A Pilot Study.” Journal of Pharmacy and Pharmacology 5 (10): 736-741.