EFFECT OF MENSTRUAL CYCLE ON THE PHARMACOKINETICS OF ENANTIOMERS OF IBUPROFEN

The purpose of this study was to characterize the influence of the menstrual cycle on the disposition of the R(-) and S(+) enantiomers of ibuprofen in healthy female volunteers. Enrolment twelve healthy female volunteers have been included in the study after obtaining written informed consent. The age ranged from 16 to 25 years and weight was from 40 to 60 kg respectively. None of the participants had received any medication during two weeks prior to the study. Study protocol was submitted in writing and was presented before the institutional ethical committee and approval was obtained. Experimental design: 600 mg of IBU (Racemic mixture) was given to each subject after overnight fasting with 150 ml water and no food was permitted during the next 4hrs. Blood samples (6ml) were drawn in to heparinized tubes from cubital vein. A predose blood sample served as an analytical blank. Subsequent blood samples were drawn 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12 and 24h after drug administration. Blood samples were centrifuged at 2000 g for 15 min. and plasma was separated. The plasma samples were stored at –800 C until HPLC analysis. The plasma samples were stored at –800 C until HPLC analysis. The samples were analyzed by Sensitive and Stereo specific high-performance liquid chromatographic method for ibuprofen in human plasma