DETERMINATION OF BIOEQUIVALENCE OF METFORMIN TABLETS USING URINARY EXCRETION DATA

Yıl 2017, Sayı: 1, 250 - 255, 09.11.2017

Eva Troja Leonard Deda

Öz

The aim of the present study was to
assess the bioequivalence of two metformin tablet formulations available in the
Albanian market (product R as reference formulation and product T as test
formulation). The bioequivalence study was performed in eighteen healthy
volunteers in a two - treatment, open, crossover design. Single oral dose (tablet
containing 850 mg of metformin) of each product was administered with one week
of washout period. Urinary concentrations of metformin were measured by
high-performance liquid chromatography (HPLC) method and pharmacokinetics
parameters were estimated by urinary excretion data. The bioequivalence was
determined by the following parameters: the cumulative amount of metformin
excreted in the urine, the total amount of metformin excreted in the urine and
the maximum urinary excretion rate of metformin. Various pharmacokinetic parameters like peak excretion rate [(dDU/dt)_max],
time for peak excretion rate (t_max), cumulative amount (D_cum0-24),
total amount of drug recovered from urine (D_cum0-∞),  elimination half-life (t_1/2),
and terminal elimination rate constant (kel), were calculated for both the
formulations.

The average cumulative amounts of metformin excreted in urine after
administration of Formulation R and Formulation T were found to be 346.3
mg (40.74% of dose) and 358.7 mg (42.2% of dose), respectively. The urinary
excretion profiles of metformin up to 24 h for both the formulations were found
to be similar. Statistical comparison (90% confidence
intervals of ratio) of pharmacokinetic parameters were in compliance with the international standards,
indicating that products R and T can be considered bioequivalents and therefore
interchangeable.

Anahtar Kelimeler

Metformin, urinary excretion, bioequivalence study

Kaynakça

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