Abstract

BIOEQUIVALENCE STUDY OF TWO INJECTABLE FLUNIXIN FORMULATIONS (FINADYNE® AND MEGFLUNIPHARE®) IN CALVES

Ashraf Elkomy* and Mohamed Aboubakr

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Finadyne® and Megfluniphare® in healthy calves after intravenous injection (IV) of both products in a dose of 2.2 mg flunixin /kg b.wt. Ten calves were divided into two groups. The first group was designed to study the pharmacokinetics of Finadyne®, while the 2nd group was designed to study the pharmacokinetics of Megfluniphare®. Each calf in both groups was IV injected with 2.2 mg flunixin /kg b.wt. Blood samples were obtained from the jugular vein and collected immediately before and at 0.08, 0.16, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 and 36 hours after a single IV injection. The disposition kinetics of Finadyne ® and Megfluniphare® following IV injection of 2.2 mg flunixin /kg b.wt, revealed that the elimination half-life (t1/2β) was (4.25 and 4.18 h) for Finadyne® and Megfluniphare® respectively. Total body clearance (Cltot) was (0.084 and 0.085 L kg-1 h-1) for Finadyne® and Megfluniphare® respectively. Volume of distribution at steady state (Vdss) was (0.193 and 0.178 L kg-1) for Finadyne® and Megfluniphare® respectively, and mean residence time (MRT) was (2.28 and 2.08 h) for Finadyne® and Megfluniphare® respectively. In conclusion: Megfluniphare® is bioequivalent to Finadyne® since the ratios of C0, AUC0-36 and AUC0-∞ (T/R) was 0.99, 0.98 and 0.98, respectively. These are within the bioequivalence acceptance range. Megfluniphare® and Finadyne ® are therefore bioequivalent and interchangeable in calves.

Keywords: .