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Comparative Pharmacokinetics of New Theophylline Preparations as Egifilin® 200 mg and 400 mg Retard Tablets After Single Dose in Healthy Volunteers

1997; Taylor & Francis; Volume: 23; Issue: 12 Linguagem: Inglês

10.3109/03639049709146158

1520-5762

I. Ürmös, G. Grézal, S. Benkö, Pál Fekete, T. Szállási, Sándor Drabant, M. Csörgó, Imre Klebovich,

Antifungal resistance and susceptibility

Pharmacokinetic properties of Egifilin® retard tablets (containing 200 or 400 mg of theophylline, EGIS Pharmaceuticals Ltd., Budapest, Hungary) 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 men indicated that there was no sex difference in the pharmacokinetics of two retard tablets.Egifilin retard tablets ensured plasma levels for almost 30 hr after single drug intake with an extremely long retard plateau between 6 and 30 hr. For study purposes, an improved rapid HPLC-UV analytical method (less than 3.5 min chromatogram) has been elaborated for the determination of theophylline in human plasma. The range of the calibration is 0.6–18 μg/ml.