Pharmacokinetic of generic formulations of zidovudine in human immunodeficiency virus infected cuban patients.
Keywords:
Generic drugs, Pharmacokinetic study, ZidovudineAbstract
Aims: The purpose of this study was to characterize pharmacokinetic parameters of zidovudine generic (AZT) in human inmunodeficiency virus (HIV) infected cuban patients.
Materials and methods: A single-dose study (300mg AZT) was made in 13 ¨naive¨ patientes for determination of the AZT concentrations in plasma and urine, fallowed an established kinetic. These concentration values were measured by reversed-phase liquid chromatography (RP-HPLC) with UV detection (λ=267nm).
Results: Pharmacokinetic parameters for zidovudine were estimated from data of concentration in plasma and urine versus time by using noncompartmental methods. The most important parameters obtained were: maximum concentration (Cmax= 3,35±1,41 μg/mL), urinary recovery (UR= 25,36±9,25 %), renal clearance (ClR= 17,56±7,78L/h), plasmatic clearance (CLp= 47,09±29,45 L/h), terminal elimination half-life (t½= 1,19±0,30h), and apparent bioavailability (F= 63,12±16,59%).
Conclusions: The values of pharmacokinetic parameters made possible to the establishment of the pharmacokinetic profile for the Cuban generic zidovudine. This is very important for future dose adjustment of patients.
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