Document Type : Original Article
Authors
1
Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt
2
Department of Pharmacology, College of Pharmacy, Al-Isra University, Amman, Jordan
Abstract
The pharmacokinetic parameters (Cmax, tmax, AUC0-10h, AUC0-∞, AUMC0-10h, AUMC0-∞, MRT, t0.5 and Kel) of cefadroxil were calcd. following single oral administration of 10 mL (equiv. to 500 mg cefadroxil) of a local generic product (Droxil suspension, The United Pharmaceutical Co., Jordan) and a ref. product (Ultracef suspension, Bristol, USA) to 24 healthy volunteers in a two-way cross-over study. After drug administration, serial blood samples were collected over a period of 10 h. The concn. of cefadroxil in the sepd. plasma was detd. by using an improved HPLC procedure. The mean values of Cmax, tmax, AUC0-10h and t0.5 were 12.87±2.71 μg/mL, 1.18±0.31 h, 39.19±5.82 μgh/mL and 1.73±0.31 h, resp. for Droxil suspension, compared to 13.62±2.62 μg/mL, 1.27±0.41 h, 41.44±5.56 μgh/mL and 1.96±0.23 h resp. for Ultracef suspension. The overall mean relative bioavailability as assessed by the AUC0-∞ (Droxil / Ultracef) was 0.95±0.08. There was no statistical significant difference (P < 0.05) in the plasma concns. or the pharmacokinetic parameters of cefadroxil after administration of the two products indicating that the two products are bioequivalent, and thus the two products are interchangeable.
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