COMPARATIVE PHARMACOKINETICS OF NEW THEOPHYLLINE PREPARATIONS AS EGIFILIN(R) 200 MG AND 400 MG RETARD TABLETS AFTER SINGLE-DOSE IN HEALTHY-VOLUNTEERS

Pharmacokinetic properties of Egifilin(R) retard tablets (containing 2 00 or 400 mg of theophylline, EGIS Pharmaceuticals Ltd., Budapest, Hun gary) were investigated in 12 healthy volunteers (six women, six men). Pharmacokinetic analysis was performed according to a one-compartment open model. The retard nature of both 200 and 400 mg tablets could be demonstrated. Comparison of the pharmacokinetic curves of women and m en indicated that there was no sex difference in the pharmacokinetics of two retard tablets. Egifilin retard tablets ensured plasma levels f or almost 30 hr after single drug intake with an extremely long retard plateau between 6 and 30 hr. For study purposes, an improved rapid HP LC-UV analytical method (less than 3.5 min chromatogram) has been elab orated for the determination of theophylline in human plasma. The rang e of the calibration is 0.6-18 mu g/ml.