PHARMACOKINETIC STUDY OF FELODIPINE AFTER SINGLE ORAL DOSE OF SLOW RELEASE FORMULATIONS IN HEALTHY VOLUNTEERS.
ANCA POP, LAURIAN VLASE, SORIN E. LEUCUŢA
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Abstract:

A pharmacokinetic study of felodipine after administration of a single oral dose of felodipine to 24 healthy volunteers was realized. Two slow release pharmaceutical products, each containing 10 mg felodipine, were involved in the study: Plendil® (AstraZeneca Pharmaceuticals) and an experimental formulation. The obtained plasmatic profiles of felodipine from the studied formulations were not similar regarding both shape and levels, so different pharmacokinetic models were built and used for characterization of the absorption and disposition of the active compound. The representative model for felodipine from Plendil® product involves a zero order absorption kinetic, lag time of absorption, bicompartmental distribution and a 1st order elimination kinetic. For the experimental product, the absorption process has two phases (two basic 1st order kinetic processes), each having a different lag time and kinetic constant. Using the representative pharmacokinetic model for felodipine from each formulation, the corresponding pharmacokinetic parameters were calculated.

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