Bioequivalence study of two oral lincomycin formulations (lincopharm 800® and lincoyosr®) in broiler chickens

  • Authors

    • Ashraf Elkomy professor of pharmacology
    • Mohamed Aboubakr
    2020-04-03
    https://doi.org/10.14419/ijpt.v8i1.30478
  • Bioequivalence, Chickens, Lincomycin, oral, Pharmacokinetics
  • 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.

     

     

     


  • References

    1. [1] Abo Sreea, T. (2014) Effect of acidifiers on pharmacokinetic and tissue residues of lincomycin in broiler chickens. Thesis presented to Faculty of Veterinary Medicine, Cairo University.

      [2] Abu-Basha EA, Gehring R, Albwa'neh SJ. (2007) Pharmacokinetics and bioavailability of spectinomycin after i.v., i.m., s.c. and oral administrationin broiler chickens. J Vet Pharmacol Ther. 30(2):139-44. https://doi.org/10.1111/j.1365-2885.2007.00825.x.

      [3] Albarellos GA, Montoya L, Denamiel GA, Velo MC & Landoni MF (2012) Pharmacokinetics and bone tissue concentrations of lincomycin following intravenous and intramuscular administrations to cats. Journal of Veterinary Pharmacology and Therapeutics, 35, 534–540. https://doi.org/10.1111/j.1365-2885.2011.01355.x.

      [4] Albarellos, GA, Montoya, L, Denamiel, GA. Velo, M.C. & Landoni, M.F. (2013) Pharmacokinetics and skin concentrations of lincomycin after intravenous and oral administration to cats. J. S. Afr. Vet. Assoc, 84(1), 1-5. https://doi.org/10.4102/jsava.v84i1.968.

      [5] Amer Aziza. (1987) Some pharmacokinetic aspects of certain antibiotics in chickens†Ph.D. Thesis presented to Faculty of Veterinary Medicine, Cairo University.

      [6] Baggot, J.D. (2001). The physiological Basis of veterinary clinical pharmacology. 1st ed. Blackwell, London. https://doi.org/10.1002/9780470690567.

      [7] Bakker, E.P. (1992) Aminoglycoside and aminocyclitol antibiotics: hygromycin B is an atypical bactericidal compound that exerts effects on cells of Escherichia coli characteristics for bacteriostatic aminocyclitols. Journal of General Microbiology, 138, 563–569. https://doi.org/10.1099/00221287-138-3-563.

      [8] Brown RB, Barza M, Brusch JL, Hashimoto Y&Weinstein L. (1975) Pharmacokinetics of lincomycin and clindamycin phosphate in a canine model. Journal of Infectious Diseases, 131, 252–260. https://doi.org/10.1093/infdis/131.3.252.

      [9] Burrows GE, Barto, PB, Martin B & Tripp ML, (1983) Comparative pharmacokinetics of antibiotics in newborn calves, lincomycin, and tylosin. American Journal of Veterinary Research, 44, 1053–1057.

      [10] Burrows, G.E. (1980) Aminocyclitol antibiotics. Journal of American Veterinary Medical Association, 176, 1280–1281.

      [11] Burrows, G.E., Morton, R.J. & Fales, W.H. (1993) Microdilution antimicrobial susceptibilities of selected gram-negative veterinary bacterial isolates. Journal of Veterinary Diagnostic Investigation, 5, 541–547. https://doi.org/10.1177/104063879300500407.

      [12] Chaleva E and Nguyen DL. (1987) Pharmacokinetic research on Pharmachem’s lincomycin hydrochloride in pigs. Veterinarni Medicina Nauki, 24, 47– 51.

      [13] Chen, M.L., V. Shah, R. Patnaik, W. Adams, A. Hussain, D. Conner, M. Mehta, H. alinowski, J. Lazor, S.M. Huang, D. Hare, L. Lesko, D. Sporn and R. Williams, (2001). Bioavailability and bioequivalence: An FDA regulatory overview. Pharmaceutical Res., 18: 1645-1650. https://doi.org/10.1023/A:1013319408893.

      [14] EL-Sayed, MGA, Hatem, ME and EL-Komy, AAA. (1989) Disposition kinetics of gentamycin in normal and endometric cows using microbiological assay. Deutsche Tierärztliche Wochenschrift, 96, 412-415.

      [15] EMEA (2002): Guidelines for the conduct of bioequivalence studies for veterinary medicinal products,1-11[http://www. emea.eu.int/pdfs/vet/ewp/001600en.pdf]2001. Accessed: 30.12.2002.

      [16] EMEA. (2006): The European Agency for Evaluation of Medicinal Products. Questions and Answers on Bioavailability and Bioequivalence Guidance.

      [17] Fan, H Wang, Z Wang, L Ye, Y and Huang, X. (2012) Pharmacokinetics of lincomycin hydrochloride and spectinomycin sulfate suspension for injection in swine. Journal of South China, 33(2), 244-247.

      [18] Giguère S. (2006) Lincosamides, pleuromutilins, and streptogramins. Antimicrobial therapy in veterinary medicine, 4th edn, 179-184.

      [19] Gouri,S. Venkatachalam,D. and Dumka,VK. (2014) Pharmacokinetics of lincomycin following single intravenous administration in buffalo calves. Trop Anim Health Prod, 46(6), 1099-102. https://doi.org/10.1007/s11250-014-0595-4.

      [20] Guerin-Faublee, V., Flandrois, J.P., Broye, E., Tupin, F. & Richard, Y. (1993) Actinomyces pyogenes: susceptibility of 103 clinical animal isolates to 22 antimicrobial agents. Veterinary Reserach, 24, 251–259.

      [21] Holloway, W.J. (1982) Spectinomycin. The Medical Clinics of North America, 66, 169–173. https://doi.org/10.1016/S0025-7125(16)31450-X.

      [22] Jeff, M., Zimmerman, L. & James, M. (2002) In vivo selection of spectinomycin-binding RNAs. Nucleic Acids Research, 30, 5425–5435. https://doi.org/10.1093/nar/gkf687.

      [23] Jordan, F.T., Forrester, C.A., Ripley, P.H. & Burch, D.G. (1998) In vitro and in vivo comparisons of valnemulin, tiamulin, tylosin, enrofloxacin, and lincomycin/spectinomycin against Mycoplasma gallisepticum. Avian Disease, 42, 738–745. https://doi.org/10.2307/1592709.

      [24] Kreizinger Z, Grózner D, Sulyok KM, Nilsson K, Hrivnák V, BenÄina D, Gyuranecz M. (2017) Antibiotic susceptibility profiles of Mycoplasma synoviae strains originating from Central and Eastern Europe. BMC Vet Res. 13(1):342. https://doi.org/10.1186/s12917-017-1266-2.

      [25] Nielsen, P and Gyrd-Hansen, N. (1998) Bioavailability of spiramycin and lincomycin after oral administration to fed and fasted pigs. Journal of Veterinary Pharmacology and Therapeutics, 21, 251–256. https://doi.org/10.1046/j.1365-2885.1998.00131.x.

      [26] Rajeevkumar, P. and Subramanian N. (2010) Determination of Lincomycin hydrochloride in pure form and pharmaceutical formulations. International Journal of Chem Tech Research, 2(4), 2052-2055.

      [27] Schwarz, S., Kehrenberg, C., Salmon, S.A. & Watts, J.L. (2004) In vitro activities of spectinomycin and comparator agents against Pasteurella multocida and Mannheimia haemolytica from respiratory tract infections of cattle. The Journal of Antimicrobial Chemotherapy, 53, 379–382. https://doi.org/10.1093/jac/dkh059.

      [28] Soback S, Ziv G, Bogin E, Cohen Z and Earon Y. (1987) Pharmacokinetic changes of several antibiotics in chickens during induced fatty liver. Research in Veterinary Science, 43, 49–54. https://doi.org/10.1016/S0034-5288(18)30740-9.

      [29] Toutain, P.L. and A. Bousquet-Melou, (2004). Bioavailability and its assessment. J. Pharmacol. Therap., 27: 455-466. https://doi.org/10.1111/j.1365-2885.2004.00604.x.

      [30] U.S. Food and Drug Administration. 2003. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products.U.S. Food and Drug Administration, Washington, DC.

      [31] Yoshida, M., Kubota, D., Yonezawa, S. et al. (1971). Transfer of dietary spiramycin into the eggs and its residue in the liver of laying hen. The Japanese Journal of Antibiotics 8, 103-110. https://doi.org/10.2141/jpsa.8.103.

      [32] Yoshida, M., Kubota, d., Yonezawa, S. et al. (1973). Transfer of dietary oxytetracycline into the eggs and its residue in the liver of laying hen. The Japanese Journal of Antibiotics 10, 29-36. https://doi.org/10.2141/jpsa.10.29.

      [33] Yoshimura, H., Osawa, N., Rasa, F. et al. (1991). Residues of oxytetracycline and oxytetracycline in eggs after medication via drinking water to laying hens. Food Additives and contaminants 8, 65-69. https://doi.org/10.1080/02652039109373956.

      [34] Ziv G and Sulman G. (1973) Penetration of lincomycin and clindamycin into milk in ewes. British Veterinary Journal, 129, 83–91. https://doi.org/10.1016/S0007-1935(17)36593-4.

  • Downloads

  • How to Cite

    Elkomy, A., & Aboubakr, M. (2020). Bioequivalence study of two oral lincomycin formulations (lincopharm 800® and lincoyosr®) in broiler chickens. International Journal of Pharmacology and Toxicology, 8(1), 60-64. https://doi.org/10.14419/ijpt.v8i1.30478

    Received date: 2020-02-29

    Accepted date: 2020-03-22

    Published date: 2020-04-03