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65918

Comparative pharmacokinetic studies of two brands of cefadroxil suspension using improved HPLC assay procedure

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Last updated: 04 Jan 2025

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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.

DOI

10.21608/bfsa.2001.65918

Authors

First Name

F.

Last Name

Mohammed

MiddleName

A.

Affiliation

Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt

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Orcid

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First Name

M.

Last Name

Quato

MiddleName

K.

Affiliation

Department of Pharmacology, College of Pharmacy, Al-Isra University, Amman, Jordan

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Volume

24

Article Issue

2

Related Issue

9954

Issue Date

2001-12-01

Receive Date

2001-02-11

Publish Date

2001-12-01

Page Start

153

Page End

159

Print ISSN

1110-0052

Online ISSN

3009-7703

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https://bpsa.journals.ekb.eg/article_65918.html

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https://bpsa.journals.ekb.eg/service?article_code=65918

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Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

Comparative pharmacokinetic studies of two brands of cefadroxil suspension using improved HPLC assay procedure

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Article

Created At

22 Jan 2023