To study the bioequivalence of the drugs Doxitron chewable tablets and Ronaxan when used in dogs

Author:

Komarov A. A.1ORCID,Engashev S. V.2ORCID,Selimov R. N.3,Mironenko A. V.4ORCID,Goncharova E. N.3ORCID,Gabidullina D. E.3ORCID

Affiliation:

1. Federal State Budgetary Educational Institution of Higher Education «Russian Biotechnological University (ROSBIOTECH)»

2. Moscow State Academy of Veterinary Medicine and Biotechnology – MVA named after K.I. Scrjabin

3. MIP Academy of Innovations LLC

4. Peoples' Friendship University of Russia named after Patrice Lumumba

Abstract

A  study  was  carried  out  to  investigate the  bioequivalence  of  the  drugs  "Doxitron chewable tablets" and "Ronaxan" when administered to dogs. Two groups of animals were formed with 4 dogs in each group. A cross-sectional study design was used for the experiment. Biological material (blood) was sampled before drug administration, and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 8, 10, 24, 30, 48, 72  h  after  drug  administration.  In  the course of the study the following parameters were controlled: concentrations of the active substance  of  the  preparations  in  the  blood plasma of dogs. The article describes in detail the scheme of the experiment, reagents and standard samples, the process of sample preparation  of  blood  plasma  samples  and HPLC-MS/MS analysis. The bioequivalence of the preparations "Doxitron chewable tablets" and "Ronaxan" is evaluated. The time to reach the maximum plasma concentration (Tmax) averaged 3.0 h for the investigational drug "Doxitron chewable tablets" and 3.0 h for the reference drug "Ronaxan". The maximum  plasma  concentration  (Cmax)  was 4007.4±964.4 ng/ml for the study drug Doxitron  Chewable  Tablets  and  3794.9±1121.5 ng/ml for the reference drug Ronaxan. The 90% confidence intervals of CmaxT/CmaxR  and  AUC0-tT/AUC0-tR ratios of doxycycline were within the range of 80-125%. The preparations  "Doxitron  chewable  tablets"  and "Ronaxan" are bioequivalent.

Publisher

Saint-Petersburg State University of Veterinary Medicine

Subject

General Medicine

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