DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20171654

Bioequivalence study of two oral amoxicillin formulations (Biocillin® and Atcomox 87%®) in broiler chickens

Mohamed Aboubakr, Mohamed Elbadawy

Abstract


Background: The present study was designed to assess the comparative bioequivalence of Biocillin® and Atcomox87%® in healthy broiler chickens after oral administration of both products in a dose of 20 mg amoxicillin base/kg.b.wt.

Methods: Twenty-four broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of Biocillin®, while the 2nd group was designed to study the pharmacokinetics of Atcomox87%®. Each broiler chicken in both groups was injected intravenously with 20 mg amoxicillin pure standard/kg.b.wt. After 15 days both groups taken orally Biocillin® and Atcomox87%®, respectively. 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 intravenous or oral administration.

Results: Amoxicillin in both products obeyed a two compartments open model following I.V. injection. The disposition kinetics of Biocillin® and Atcomox87%® following oral administration of 20 mg amoxicillin base/kg.b.wt. revealed that the maximum blood concentration [Cmax] were 10.79 and 10.30 μg/ml and attained at [tmax] of 0.90 and 0.86 hours, respectively. The mean systemic bioavailability of amoxicillin in Biocillin® and Atcomox 87%® after oral administration in healthy chickens was 64.15 and 65.54%, respectively.

Conclusions: Atcomox 87%® is bioequivalent to Biocillin® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.95, 0.91 and 0.90 respectively. These are within the bioequivalence acceptance range. Biocillin® and Atcomox87%® are therefore bioequivalent and interchangeable.


Keywords


Amoxicillin, Bioequivalence, Chickens

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References


Sousa JC. Manual de antibióticos antibacterianos. Fernando Pessoa University, Oporto, Portugal. 2005;219-21.

Pfizer. Clavamox® for cats and dogs. Available from: http://animalhealth.pfizer.com/sites/pahweb/US/EN/Products/Documents/AIF0504022.pdf

APVMA. Vetrimoxin 50 Soluble Powder. Available from: http://www.apvma.gov.au/advice_summaries/40946.pdf.

Anadón A, Martinez-Larranaga MR, Diaz MJ, Bringas P, Fernandez MC, Martinez MA, et al. Pharmacokinetics of amoxicillin in broiler chickens. Avian Pathology. 1996;25:449-58.

Anfossi P, Zaghini A, Grassigli G, Menotta S, Fedrizii G. Relative oral bioavailability of microgranulated amoxicillin in pigs. J. Vet. Pharmacol. Ther. 2002;25;329-34.

Naoaki M, Kumiko K, Fusao K, Eiko K, Peter V. Isolation and characterization of Campylobacter, Helicobacter, and Anaerobiospirillum strains from a puppy with bloody diarrhea. Vet. Microbiol. 2002;87:353-64.

Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D. Bioavailability and bioequivalence: An FDA regulatory overview. Pharmaceutical Res. 2001;18:1645-50.

Toutain, PL, Bousquet-Melou A. Bioavailability and its assessment. J. Vet. Pharmacol. Therap. 2004;27:455-66.

Arret B, Johnson DP, Kirshbaum A. Outline of details for microbiological assays of antibiotics: second revision. J Pharm Sci. 1971;60(11):1689-94.

Baggot JD. The physiological Basis of veterinary clinical pharmacology. 1st ed. Blackwell, London; 2001.

EMEA. Guidelines for the conduct of bioequivalence studies for veterinary medicinal products,1-11. Available from: http://www.emea.eu.int/pdfs/vet/ewp/001600en.pdf.

EMEA. The European Agency for Evaluation of Medicinal Products. Questions and Answers on Bioavailability and Bioequivalence Guidance; 2006.

Spyker DA, Rugioski RJ, Vann RL, Obrien WM. Pharmacokinetics of amoxicillin: dose dependence after intravenous, oral and intramuscular administration. Antimicrobial Agents and Chemotherapy. 1977;11:132-41.

Rutgers LJE, Van M. Effect of the injection site on the bioavailability of amoxycillin trihydrate in dairy cows. Journal of Veterinary Pharmacology and Therapeutics. 1980;3:125-32.

Wilson WD, Spensley MS, Baggot JD, Hietala SK. Pharmacokinetics and estimated bioavailability of amoxicillin in mares after intravenous, intramuscular, and oral administration. American Journal of Veterinary Research. 1988;49:1688-94.

Montesissa C, Carli S, Sonzogni O, Garlappi R. Pharmacokinetics of sodium amoxicillin in horses. Research in Veterinary Science. 1988;44:233-6.

Ten Voorde G, Broeze J, Hartman EG, Van Gogh H. The influence of the injection site on the bioavailability of ampicillin and amoxycillin in beagles. Veterinary Quarterly. 1990;12:73-79.

Craigmill AL, Pass MA, Wetzlich S. Comparative pharmacokinetics of amoxicillin administered intravenously to sheep and goats. Journal of Veterinary Pharmacology and Therapeutics. 1992;15:72-7.

Dorresein GM, Van Gogh H, Rinzema JD, Buttelaar MN. Comparative study of ampicillin and amoxycillin after intravenous, intramuscular and oral administration in homing pigeons (Columba livia). Research in Veterinary Science. 1987;42:343-8.

Khanifor HN, Srivastava AK, Paul BS, Malik JK. Kinetic disposition and biodistribution of amoxycillin in Bubalis bubalis. Zentralblatt für Veterinärimedizin A. 1986;33:212-8.

Palmer GH, Bywater RJ. Bioavailability of semisynthetic penicillins in the bovine. Pharmacologie et Toxicologie Vétérinaires, les Colloques de l'INRA. 1982;8:439-42.

Brogden RN, Heel RC, Speight TM, Avery GS. Amoxycillin injectable: a review of its antibacterial spectrum, pharmacokinetics and therapeutic use. Drugs. 1979;18:169-84.

Alvinerie M, Lcoste E, Sutra JF, Chartier C. Some pharmacokinetic parameters of Eprinomectin in goats following pour-on Administration. Vet. Res. Comm. 1999;23:449-55.

Rowlan M, Tozer TN. Clinical Pharmacology: Concepts and Applications. 2nd ed. Philadelphia: Lea and Febiger. 1989;479-83.

Baggot JD. Principles of Drug Disposition in Domestic Animals: The Basis of Veterinary Clinical Pharmacology. Toronto: WB Saunders. 1977;1-238.

Conzelman GM, Babish JG, Davidson JN, Mcmillan RA, Copelan DD. Pharmacokinetics of 1-cyclopropyl-6-fluoro- 1,4-dihydro-4-oxo- 7-(4-ethyl- I -piperazyl)-3-quinolonecarboxylic acid (Bay Vp 2674) in chickens. Proc West Pharmacol Soc. 1987;30:393-5.

Dorresein GM, Rinzema JD, Buttelaar MN. Tissue distribution of amoxycillin after oral and intramuscular administration to pigeons (Columba Ovia). Avian Pathology. 1986;15,663-76.

Soback S, Bor A, Kurtz B, Paz R, Ziv G. clavulanate-potentiated amoxycillin: in vitro antibacterial activity and oral bioavailability in calves. Journal of Veterinary Pharmacology and Therapeutics. 1987;10:105-13.

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