Bioavailability investigation of two different oral formulations of methylprednisolone
| Autor: | Karlheinz Doser, Richard Guserle, Eva Bungers, Dieter Schaarschmidt, Ursula Geister |
|---|---|
| Rok vydání: | 2000 |
| Předmět: |
Adult
Male Quality Control Cmax Anti-Inflammatory Agents Biological Availability Pharmacology Bioequivalence High-performance liquid chromatography Methylprednisolone Pharmacokinetics Double-Blind Method Oral administration Drug Discovery medicine Humans Chromatography High Pressure Liquid Chromatography Cross-Over Studies Chemistry Middle Aged Crossover study Bioavailability Therapeutic Equivalency Area Under Curve Calibration Female Spectrophotometry Ultraviolet medicine.drug |
| Zdroj: | Arzneimittel-Forschung. 50(3) |
| ISSN: | 0004-4172 |
| Popis: | Two different oral methylprednisolone (CAS 83-43-2) formulations (Methylprednisolon-ratiopharm 8 mg tables as test preparation (T) and tablets of a reference preparation (R)) were investigated in 16 healthy volunteers in order to prove bioequivalence between these preparations. A single 8 mg oral dose was given according to a randomised two-way crossover design in the fasted state. Blood samples for determination of methylprednisolone plasma concentrations were collected at pre-defined time points up to 16 h following drug administration. A washout period of 3 days separated both treatment periods. Methylprednisolone plasma concentrations were determined by means of a validated HPLC method. Values of 342.53 ng.h/ml (test preparation) and 336.61 ng.h/ml (reference preparation) for the parameter AUC0-infinity demonstrate an nearly identical extent of drug absorption. Maximum concentrations (Cmax) of 66.58 ng/ml and 70.51 ng/ml were achieved for test and reference preparation. Time to reach maximum plasma concentration (tmax) was 2.2 h for both preparations. Cmax and AUC0-infinity-values were tested parametrically by the two one-sided t-test procedure. Bioequivalence was concluded if the 90% confidence intervals of the T/R-ratios were in the range of 80-125% for AUC0-infinity and 70-143% for Cmax. Based on the results obtained in this study, bioequivalence between Methylprednisolone ratiopharm and the reference preparation was demonstrated. |
| Databáze: | OpenAIRE |
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