Comparative pharmacokinetic studies of two brands of cefadroxil suspension using improved HPLC assay procedure | ||||
| Bulletin of Pharmaceutical Sciences Assiut University | ||||
| Article 4, Volume 24, Issue 2, December 2001, Page 153-159 PDF (415.83 K) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/bfsa.2001.65918 | ||||
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| Authors | ||||
| F. A. Mohammed1; M. K. Quato2 | ||||
| 1Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt | ||||
| 2Department 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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