Development and pharmacokinetic study of the original dosage form - gliclazide suspension

Relevance: one of the most common forms of diabetes mellitus (DM) is type 2 diabetes mellitus. A personalized approach to diabetes therapy presupposes adeguate glycemie control and the availability of original drugs with various pharmacokinetic parameters, incl. bioavailability. One of these dosage forms is a suspension that meets a number of good manufacturing practice (GMP) reguirements and has several advantages over other dosage forms. Purpose of the work: to study the bioavailability of Gliclazidum from a suspension in comparison with a tablet dosage form. Material and methods: the study of the bioavailability of Gliclazidum from the suspension and tablets was carried out on male Vistar rats weighing 190-200 grams. The animals were injected with the developed suspension of Gliclazidum and the reference drug - tablets "Diabeton MV" ("ServierRus", Russia, active ingredient - Gliclazidum). Form of administration of drugs - intragastrically at the rate of 60 mg / kg of body weight of animals. Blood sampling was carried out at intervals from 2 to 24 hours after drug administration. Extraction of Gliclazidum from blood plasma was carried out with dichloromethane at a pH of 9.5, the extract was dried, dissolved in 100 pi of methanol, and the solution was analyzed by liguid chromatography. The Gliclazidum content was calculated using the internal standard method. A calibration graph was preliminarily constructed, where a "blank" (not containing gliclazide and anecaine - internal standard) blood plasma was used. The study was carried out on a liguid microcolumn chromatograph "Milichrom - A02" with a UV spectrophotometric detector. Results: it was found that the concentration of Gliclazidum after 2, 4 hours, as well as its residual concentration in the blood plasma of rats 12 and 24 hours after administration of the suspension is higher than after administration of tablets. The data obtained indicate a higher bioavailability of the drug from the suspension compared to the tableted dosage form. Conclusions: a higher bioavailability of Gliclazidum from a suspension than from tablets has been experimentally established, which confirms the feasibility of its medical use.

suspension of gliclazide, pharmacokinetics of gliclazide, determination of gliclazide in blood plasma