Effect of Menstrual Cycle on the Pharmacokinetics of Naproxen

Author(s): G. Sandhya Rani*, D. R. Krishna and V. Venkateswarlu

Abstract: The purpose of this research was to characterize the influence of the menstrual cycle on the pharmacokinetics of Naproxen in healthy female volunteers. Gender differences in pharmacokinetics and pharmacodynamics of drugs have been recognized for some time. The large variations in hormone levels throughout the menstrual cycle could potentially have a significant effect on the metabolism of drugs. The 2-Aryl propionic acid (2-APA) derivatives are currently an important group of NSAIDS. A common structural feature of 2-APA NSAIDS is a SP3–hybridized tetrahedral chiral carbon atom within the propionic acid side chain moiety with the S-(+) Enantiomer possessing most of the beneficial anti-inflammatory activity. Twelve healthy female volunteers participated in the study of age ranging from 16 to 25 years and weight in the range of 40 to 60 kg. The days were 3rd, 13th, 23rd, day of the menstrual cycle. A single oral dose of 100 mg of was given to each subject with 150 ml water. A predose blood sample served as an analytical blank. Subsequent blood samples were drawn at 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12 hrs. Chiral columns were available for the separation of enantiomers of profens. The samples were analyzed by Sensitive and Stereo specific high-performance liquid chromatographic method for Naproxen in human plasma.

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