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概要

Study to Determine Bioequivalence of Three Ceftiofur Crystalline Free Acid in Pigs

Luis Ocampo-Camberos, Minerva Monroy-Barreto, Agustín Nieto-Carmona, Juan Angel Jaime, Lilia Gutierrez

Background: Antimicrobial resistance has the potential to affect sustainable development goals in food-producing livestock. Poor quality antibacterial pharmaceutical preparations significantly contribute to heighten this problem. Bioequivalence (BE) studies are very important for the development of dependable pharmaceutical preparations.

Methods: In this trial 3 Ceftiofur Crystalline Free Acid (CCFA) pharmaceutical preparations (1 reference and 2 experimental), intended for swine medicine and freely sold in Mexico, were tested to assess as to whether or not they can be regarded as generic ones.

Results: Three commercially available products of CCFA containing 200 mg of ceftiofur crystalline free acid were compared taking Excede® brand as reference preparation and preparations A and B as experimental ones. Thirty-six Landrace/Duroc pigs randomly divided into three groups received a single injection in phase 1 and after a washout period the same procedure was repeated in a crossover phase. Based on PK data obtained through HPLC analytical recollection of serum concentrations of ceftiofur, it is possible to conclude that preparations A and B cannot be regarded as bioequivalent to Excede® in pigs given that AUC0-168, MRT and K½el values obtained from preparations A and B are statistically different beyond a 20% limit from the corresponding ones obtained for the reference preparation, with confidence intervals >0.05.

Conclusion: Based on the area under the concentration vs time curve from zero to 168 h, mean residence time, and elimination constant values obtained from preparations A and B it is possible to conclude that they cannot be regarded as bioequivalent to Excede® in pigs (CI>0.05).