Abstract

The present study was designed to assess the comparative bio-equivalence of Lincopharm 800® and Lincoyosr® in healthy broiler chicken after oral administration of both products in a dose of 20 mg lincomycin base/kg b.wt. Twenty four broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of Lincopharm 800®, while the 2nd group was designed to study the pharmacokinetics of Lincoyosr®. Each broiler chicken in both groups was orally administered with 20 mg lincomycin base/kg b.wt. Blood samples were obtained from the wing vein and collected immediately before and at 0.08, 0.16, 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after a single oral administration. The disposition kinetics of Lincopharm 800® and Lincoyosr® following oral administration of 20 mg lincomycin base /kg b.wt, revealed that the maximum blood concentration of lincomycin [Cmax] were 4.81 and 4.62 μg/ml and attained at [tmax] of 1.36 and 1.35 hours, respectively. In conclusion: Lincoyosr® is bioequivalent to Lincopharm 800® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.96, 0.92 and 0.91 respectively. These are within the bioequivalence acceptance range. Lincoyosr® and Lincopharm 800® are therefore bioequivalent and interchangeable.  Â

Highlights

  • Lincosamides is a group of monoglycoside antibiotics containing amino-acid like side chain

  • Lincomycin is used in chickens either alone or in combination with other antibiotics for the treatment of air-sacculitis caused by either M. synoviae or M. gallisepticum and complicated chronic respiratory diseasecaused by E. coli and M. gallisepticum (Abu Basha et al, 2007)

  • The aim of this study is to evaluate bioequivalence of two oral lincomycine water soluble powders (Lincopharm 800® and Lincoyosr®) after oral administration of a single dose in broiler chickens

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Summary

Introduction

Lincosamides is a group of monoglycoside antibiotics containing amino-acid like side chain. Lincomycin is a member of the lincosamide antibiotics, mainly active against Staphylococci, Streptococci and anaerobic bacteria including Bacteroides fragilis (Giguère, 2006). It is used alone or in combination with other drugs in poultry for oral treatment of bacterial enteric infections, control of respiratory infections and growth enhancement. The bioavailability and bioequivalence studies play an important role in determining therapeutic efficacy to register the generic drug products according to the Food and Drug Administration (FDA) regulations (Chen et al, 2001). The aim of this study is to evaluate bioequivalence of two oral lincomycine water soluble powders (Lincopharm 800® and Lincoyosr®) after oral administration of a single dose in broiler chickens

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