To study the bioequivalence of the drugs Doxitron chewable tablets and Ronaxan when used in dogs
https://doi.org/10.52419/issn2072-2419.2023.4.143
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.
About the Authors
A. A. Komarov
Federal State Budgetary Educational Institution of Higher Education «Russian Biotechnological University
(ROSBIOTECH)»
Russian Federation
Russian Federation
Doctor of Biological Sciences, Professor of the RAS
S. V. Engashev
Moscow State Academy of Veterinary Medicine and Biotechnology – MVA named after K.I. Scrjabin
Russian Federation
Russian Federation
Doctor in Veterinary Science, Academician of the RAS, Professor
R. N. Selimov
MIP Academy of Innovations LLC
Russian Federation
Russian Federation
Candidate in Veterinary Science, Head of the Laboratory for the Study of Pharmacokinetics and Metabolism of Drugs
A. V. Mironenko
Peoples' Friendship University of Russia named after Patrice Lumumba
Russian Federation
Russian Federation
Candidate in Veterinary Science, Master of the Institute of Biochemical Technologies and Nanotechnologies
E. N. Goncharova
MIP Academy of Innovations LLC
Russian Federation
Russian Federation
Candidate in Chemis-try Science, Senior Researcher, Laboratory for the Study of Pharmacokinetics and Metabolism of Drugs
D. E. Gabidullina
MIP Academy of Innovations LLC
Russian Federation
Russian Federation
Senior Researcher, Laboratory for the Study of Pharmacokinetics and Metabolism of Drugs
References
1. Miroshnikova M. S. Tetracycline antibiotics in animal husbandry and veterinary medicine //Shag v nauki. - 2021. - №. 2. - С. 10-20.
2. Decision of the Council of the Eurasian Economic Commission of 21.01.2022 N 1 "On the Rules for regulating the circulation of veterinary medicines on the customs territory of the Eurasian Economic Union".
3. Rishko O. Tetracyclines: a look from the past to the future // Livestock of Russia. - 2019. - №. 1. - С. 36-37.
4. Engashev S.V., Engasheva E.S., Mironenko A.V. Method for treating respiratory and gastrointestinal diseases of farm animals. Patent for invention 2796827 C1, 05/29/2023.
5. Antimicrobial Therapy in Veterinary Medicine, Fifth Edition. Edited by Steeve Giguère, John F. Prescott and Patricia M. Dowling. 2013 John Wiley & Sons, Inc.
6. Davoust B, Keundjian A, Rous V, et al. Validation of chemoprevention of canine monocytic ehrlichiosis with doxycycline. Vet Microbiol 2005; 107: 279–283.
7. Ganiere JP, Medaille C, Mangion C. Antimicrobial drug susceptibility of Staphylococcus intermedius clinical isolates from canine pyoderma. J Vet Med B Infect Dis Vet Public Health 2005; 52: 25–31.
8. Holmes N, Charles P. Safety and efficacy review of doxycycline. Clin Med Ther 2009; 1: 471–482.
9. Maaland MG, Papich MG, Turnidge J, Guardabassi L. Pharmacodynamics of doxycycline and tetracycline against Staphylococcus pseudintermedius: proposal of canine-specific breakpoints for doxycycline. J Clin Microbiol. 2013 Nov;51(11):3547-54.
10. Murray CK, Hospenthal DR. Determination of susceptibilities of 26 Leptospira sp. serovars to 24 antimicrobial agents by a broth microdilution technique. Antimicrob Agents Chemother 2004; 48: 4002–4005.
11. Papich Handbook of Veterinary Medicine, Fifth Edition. Mark G.Papich. 2021 Elsevier, Inc.
12. Veterinary Pharmacology and Therapeutics, Tenth Edition. Edited by Jim E. Riviere and Mark G. Papich. 2018 JohnWiley & Sons.
13. Pappas G, Akritidis N, Bosilkovski N, et al. Brucellosis. N Engl J Med 2005; 352: 2325–2336.
14. Plumb, D.C. (2011). Plumb's veterinary drug handbook. Stockholm, Wis: Pharma-Vet.
15. Order of the Ministry of Agriculture of the Russian Federation dated March 6, 2018 N 101 “On approval of the rules for conducting preclinical studies of a medicinal product for veterinary use, clinical trials of a medicinal product for veterinary use, bioequivalence studies of a medicinal product for veterinary use”.
16. Pudjiatmoko, Fukushi H, Ochiai Y, et al. In vitro susceptibility of Chlamydia pecorum to macrolides, tetracyclines, quinolones and beta-lactam. Microbiol Immunol 1998; 42: 61–63.
17. Ross JE, Jones RN. MIC quality control guidelines for doxycycline when testing grampositive control strains by the reference methods. Diagn Microbiol Infect Dis 2004; 50: 295–297.
18. Speakman AJ, Dawson S, Corkill JE, et al. Antibiotic susceptibility of canine Bordetella bronchiseptica isolates. Vet Microbiol 2000; 71: 193–200.
19. Summary of Product Characteristics - Doxycare Flavour 200 mg Tablets for Cats and Dogs.
20. EMA/CVMP/VICH/463202/2009 VICH topic GL49: Studies to evaluate the metabolism and residues kinetics of veterinary drugs in human food-producing animals: validation of analytical methods used in residue depletion studies.
21. EMEA. Guideline in bioanalytical method validation. European Medicines Agency. Committee for medicinal products for human use: London (2011).
Review
For citations:
Komarov A.A., Engashev S.V., Selimov R.N., Mironenko A.V., Goncharova E.N., Gabidullina D.E. To study the bioequivalence of the drugs Doxitron chewable tablets and Ronaxan when used in dogs. International Journal of Veterinary Medicine. 2023;(4):143-153. (In Russ.) https://doi.org/10.52419/issn2072-2419.2023.4.143
Views:
273
Email this article 