PHARMACOKINETICS, BIO-EQUIVALENCE AND TISSUE RESIDUES OF TWO ORAL COLISTIN FORMULATIONS IN BROILER CHICKENS
Abstract
Objective: The present study was carried out to investigate and provide an overview of the pharmacokinetics, bio-equivalence and tissue residues of colistin in two oral tested products, BAC-Liquido® (Interchemi Co.) and Coline-L® (Medmac Co.) in healthy broiler chickens.
Methods: The comparative pharmacokinetics, bio-equivalence, blood and tissue residues of BAC-Liquido® and Coline-L® in broiler chickens was studied after oral administration of both products in a dose of 100.000 IU colistin base/kg. b. wt once daily for 5 consecutive days.
Results: Colistin in both products obeyed a two compartments open model following I. V administration. The disposition kinetics of BAC-Liquido® and Coline-L® following oral administration of 100.000 IU colistin base/kg. b. wt revealed that the maximum blood concentration [Cmax.] were 5.10 and 4.95 µg/ml and attained at [tmax.] of 5.90 and 6.40 h, respectively. Colistin in BAC-Liquido® and Coline-L® was eliminated with half-lives [t1/2β] equal to 3.15 and 2.89 h, respectively. The mean systemic bioavailability of colistin in BAC-Liquido® and Coline-L® following oral administration in healthy chickens was 3.75 and 4.05%, respectively. The blood (µg/ml) and tissue (µg/g) residues of Coline-L® and BAC-Liquido® following repeated oral administrations showed that liver, kidney; lung, breast, and thigh muscles contained the limited colistin residues. Colistin in both preparations was completely disappeared from all tissues at 24 h following the last oral dose (except liver 48 h).
Conclusion: It was concluded that Coline-L® is bioequivalent to BAC-Liquido® since Cmax test/Cmax reference and AUCtest/AUCreference ratios were 0.97 and 1.06, respectively. Chickens should not be slaughtered for human consumption within treatment and could be consumed after the discontinuation of the treatment (except liver, withdrawal time 48 h) of either BAC-Liquido® or Coline-L®.
Keywords: Pharmacokinetics, Colistin, Broiler chickens, Bioavailability, Tissue residue.
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References
Furusawa N. Spiramycin, oxytetracycline and tissues of laying hens. Zentralbl Veterinarmed A 1999;46:599-603.
FAO/WHO. Codex Alimentarius Commission. Codex Committee On Residues of Vet. Drugs In Foods; 2006.
Li J, Nation RL, Milne RW, Turnidge JD, Coulthard K. Evaluation of colistin as an agent against multi-resistant Gram-negative bacteria. Int J Antimicrob Agents 2005;25:11-25.
Evans ME, Feola DJ, Rapp RP. Polymyxin B sulfate and colistin: old antibiotics for emerging multiresistant gram-negative bacteria. Ann Pharmacother 1999;33:960-7.
Harvey S. Antimicrobial drugs. In: AR Gennaro, ed. Remington's Pharmaceutical Sciences. 17th ed. Easton, PA: Mack Publishing Co; 1985. p. 1158-233.
Roadaut B. Depletion of colistin in eggs following medication of laying hens. Vet Q 1989;11:183-5.
Food Safety Commission. Summary Report on Vet. Med./Feed Additive Evaluation Report for Colistin; 2008.
Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, et al. Bioavailability and bioequivalence: An FDA regulatory overview. Pharm Res 2001;18:1645-50.
Arret B, Johnson DP, Kirshbaum A. Outline of details for microbiological assay of antibiotics. 2nd Revision. J Pharm Sci 1971;60:1689-94.
Tsai GE, Kondo F. Improved agar diffusion method for detecting residual antimicrobial agents. J Food Prot 2001;64:361-6.
Yoshida M, Kubota D, Yonezawa S, Nakamura H, Azechi H, Terakado N. Transfer of dietary spiramycin into the eggs and its residue in the liver of laying hen. Jpn Poult Sci 1971;8:103-10.
Yoshida M, Kubota D, Yonezawa S, Nakamura H, Yamaoka R, Yoshimura H. Transfer of dietary erythromycin into the eggs and its residue in the liver of laying hen. Jap Poult Sci 1973;10:29-36.
Roudaut B, Moretain JP, Biosseau J. Excretion of oxytetracycline in the egg after medication of laying hens. Food Addit Contam 1987;4:297–307.
Roudaut B, Moretain JP. Residues of macrolide antibiotics in eggs following medication of laying hens. Br Poult Sci 1990;31:661-75.
Omija B, Mittema ES, Maitho TE. Oxytetracycline residue levels in chicken eggs after oral administration of medicated drinking water to laying hens. Food Addit Contam 1994;11:641-7.
Ziv G, Sulman FG. Passage of polymyxins from serum into milk in ewes. Am J Vet Res 1973;34:317-22.
Dudhani RV, Nation RL, Li J. Evaluating the stability of colistin and colistin methanesulphonate in human plasma under different conditions of storage. J Antimicrob Chemother 2010;65:1412–5.
Wallace SJ, Li J, Rayner CR, Coulthard K, Nation RL. Stability of colistin methanesulfonate in pharmaceutical products and solutions for administration to patients. Antimicrob Agents Chemother 2008;52:3047–51.
Alvinerie M, Lacoste E, Sutra JF, Chartier C. Some pharmacokinetic parameters of eprinomectin in goats following pour-on administration. Vet Res Commun 1999;23:449-55.
Baggot JD. Some aspects of clinical pharmacokinetics in veterinary medicine I. J Vet Pharmacol Ther 1987;1:5-18.
European Agency for the evaluation of european medicines agency (EMEA). Committee for veterinary medicinal products (Tylosin) extension to eggs; Summary Report . The European Agency for The Evaluation of Medicinal Products: London; 2002. p. E14 4HB, UK.
Tomasi L, Giovannetti L, Rondolotti A, Della Rocca G, Stracciari GL. Depletion of the residues of colistin and amoxicillin in turkeys following simultaneous subcutaneous administration. Vet Res Commun 1996;20:175-82.