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Bioequivalence in the Sheep of Two Tilmicosin Preparations

Year 2019, Volume: 9 Issue: 1, 28 - 31, 30.04.2019
https://doi.org/10.26650/experimed.2019.19005

Abstract

DOI:
10.26650/experimed.2019.19005


Objective: The aim of this study is to
evaluate the bioequivalence of a generic product containing tilmicosin
phosphate in comparison to the original preparation.

Material and Method: The original and
generic products were applied to 20 healthy Kıvırcık sheep at a single dose (10
mg/kg, s.c.) according to a cross- over design. Blood samples were taken before
and at 15 and 30th minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96th hours
following injections. The serum concentrations of tilmicosin were measured by
high pressure liquid chormatography (HPLC) following extraction process.
Pharmacokinetic parameters were calculated using non-compartmental model
analysis. AUC (0-72) and Cmax were based basis for evaluation of
bioequivalence.  The bioequivalence
criterion was AUC 80-125 % (90 % confidence interval).

Result: Compared to the original product,
AUC (0-72) of the generic product was 105,7% and the Cmax was 106,6%.







Conclusion: It is concluded that the two
products are bioequivalent and could be used interchangeably in conditions
where they are indicated. 

Cite this article as: Şahin E, Yıldırım M.
Bioequivalence in the Sheep of Two Tilmicosin Preparations. Experimed 2019;
9(1): 28-31.

References

  • 1. Avcı T (2010): Sığırlarda Parenteral yolla uygulanan bazı makrolid grubu antibiyotiklerin sütteki seviyelerinin Belirlenmesi. (Doktora Tezi) s.29. 2. Caoa X-Y, Dongb M, Shen J-Z et al. Tilmicosin and tylosin have anti-inflammatory properties via modulation of COX-2 and iNOS gene expression and production of cytokines in LPS-induced macrophages and monocytes. Int J Antimicrob Agents 2006; 27: 431-8. 3. §EMEA (2001): Note for Guıdance on the investigation of bioavailability and Bioequivalence. Londra Committee for proprietary medicinal product (CPMP). 4. EMEA (2010). Guideline on the conduct of bioequivalence studies for veterinary medicinal products. Draft. Londra. Committee for Medicinal Products for Veterinary Use. 5. FAO (2006): Guidance for Industry Bioequivalence Guidance. U.S.A. Center for veterinary Medicine (CVM). 6. FDA (2005): Micotil 300. Freedom of information summary Supplemental New Animal Drug Application NADA 140-929. 7. Giguère S. (2006). Macrolides, Azalides, and Ketolides. 191-206. In: Prescott JF (Ed), Antimicrobial Therapy in Veterinary Medicine. Blackwell Publishing, US. 8. Kaya S. (2002). Makrolidler. 335-343. In: Kaya S, Pirinçci İ, Bilgili A (Ed), Veteriner Hekimliğinde Farmakoloji. Ankara Medisan Yayınevi, Ankara. 9. Lakritz J, Tyler JW, Marsh A, et al. Tilmicosin reduces lipopolysaccharide-stimulated bovine alveolar macrophage prostaglandin E(2) production via a mechanism involving phospholipases. Vet Ther 2002; 3: 7-21. 10. McNeil FD. Tilmicosin. Food &Drug Administration www.fao.org/docrep/w4601e/w4601e0e.html (10.04.2008). 11. Modric, S, Webb AI, Derendorf H. Pharmacokinetics and pharmacodynamics of tilmicosin in sheep and cattle. J Vet Pharmacol Therap 1998; 21: 444-52. 12. Moran JW, Turner JM, Coleman MR. Determination of tilmicosin in Bovine and Porcine Sera by Liquid Chromatography. J AOAC Int 1997; 80: 1183-9. 13. Naccari F, Giofre F, Pellegrino M, et al. Effectiveness and kinetic behavior of tilmicosin in the treatment of respiratory infections in sheep. Vet Rec 2001: 148; 773-6. 14. Ramadan A. Pharmacokinetics of tilmicosin in serum and milk of goats. Res Vet Sci 1997: 62; 48-50. 15. Rui P, Shen J, Li J, et al. The Pharmacokinetics of Tilmicosin administrated Intravenously and Subcutaneously in Healthy Sheep. Acta Veterinaria et Zootechnica Sinica 2005: 36; 296-300. 16. Shen J, Li C, Jiang H, et al. Pharmacokinetics of tilmicosin after oral administration in swine. AJVR 2005: 66; 1071-4. 17. Tountain PL, Koritz GD. Veterinary drug bioequivalence determination. J. Vet Pharmacol Therap 1997; 20: 79-90. 18. Zhang J, Li J, Miao X, et al. Pharmacokinetics of Tilmicosin in Sheep. Acta Veterinaria et Zootechnica Sinica 2004: 35; 560-4.

İki Tilmikosin Preparatının Koyunlarda Biyoeşdeğerliği

Year 2019, Volume: 9 Issue: 1, 28 - 31, 30.04.2019
https://doi.org/10.26650/experimed.2019.19005

Abstract

DOI:
10.26650/experimed.2019.19005


Amaç: Bu çalışmanın amacı, tilmikosin
fosfat içeren bir jenerik ürünün orijinal preparata biyoeşdeğerliğini değerlendirmektir. 

Gereç ve Yöntem:  20 adet Kıvırcık ırkı sağlıklı koyuna tek doz
(10 mg/kg, s.c.)  çapraz tasarım esasına
göre orijinal ve jenerik ürün uygulandı. 0. dakika ve  uygulama sonrasında 15., 30. dakika ile
1.,2., 3., 4., 6., 8., 12., 24., 48., 72. ve 96. saatlerde kan örnekleri
toplandı. Serum tilmikosin düzeyleri, ekstraksiyon işlemini takiben yüksek basınçlı
likit kromatografisi  (HPLC) ile ölçüldü.
Farmakokinetik parametreler non-kompartmantal model analizi kullanılarak
hesaplandı. Biyoeşdeğerlik değerlendirilmesinde EAA(0-72) ve Cmax parametreleri
temel alındı. Biyoeşdeğerlik kriteri EAA %80-125 (%90 güven aralığı) olarak
kabul edildi.

Bulgular: Orijinal ilaca kıyasla jenerik
ilacın EAA(0-72)  oranı % 105,7; Cmax
oranı ise %106,6 olarak saptandı.







Sonuç: Sonuç olarak, iki ürünün biyoeşdeğer
olduğu ve endike oldukları alanlarda birbirlerinin yerine kullanabilecekleri söylenebilir.

Cite this article as: Şahin E, Yıldırım M.
Bioequivalence in the Sheep of Two Tilmicosin Preparations. Experimed 2019;
9(1): 28-31.

References

  • 1. Avcı T (2010): Sığırlarda Parenteral yolla uygulanan bazı makrolid grubu antibiyotiklerin sütteki seviyelerinin Belirlenmesi. (Doktora Tezi) s.29. 2. Caoa X-Y, Dongb M, Shen J-Z et al. Tilmicosin and tylosin have anti-inflammatory properties via modulation of COX-2 and iNOS gene expression and production of cytokines in LPS-induced macrophages and monocytes. Int J Antimicrob Agents 2006; 27: 431-8. 3. §EMEA (2001): Note for Guıdance on the investigation of bioavailability and Bioequivalence. Londra Committee for proprietary medicinal product (CPMP). 4. EMEA (2010). Guideline on the conduct of bioequivalence studies for veterinary medicinal products. Draft. Londra. Committee for Medicinal Products for Veterinary Use. 5. FAO (2006): Guidance for Industry Bioequivalence Guidance. U.S.A. Center for veterinary Medicine (CVM). 6. FDA (2005): Micotil 300. Freedom of information summary Supplemental New Animal Drug Application NADA 140-929. 7. Giguère S. (2006). Macrolides, Azalides, and Ketolides. 191-206. In: Prescott JF (Ed), Antimicrobial Therapy in Veterinary Medicine. Blackwell Publishing, US. 8. Kaya S. (2002). Makrolidler. 335-343. In: Kaya S, Pirinçci İ, Bilgili A (Ed), Veteriner Hekimliğinde Farmakoloji. Ankara Medisan Yayınevi, Ankara. 9. Lakritz J, Tyler JW, Marsh A, et al. Tilmicosin reduces lipopolysaccharide-stimulated bovine alveolar macrophage prostaglandin E(2) production via a mechanism involving phospholipases. Vet Ther 2002; 3: 7-21. 10. McNeil FD. Tilmicosin. Food &Drug Administration www.fao.org/docrep/w4601e/w4601e0e.html (10.04.2008). 11. Modric, S, Webb AI, Derendorf H. Pharmacokinetics and pharmacodynamics of tilmicosin in sheep and cattle. J Vet Pharmacol Therap 1998; 21: 444-52. 12. Moran JW, Turner JM, Coleman MR. Determination of tilmicosin in Bovine and Porcine Sera by Liquid Chromatography. J AOAC Int 1997; 80: 1183-9. 13. Naccari F, Giofre F, Pellegrino M, et al. Effectiveness and kinetic behavior of tilmicosin in the treatment of respiratory infections in sheep. Vet Rec 2001: 148; 773-6. 14. Ramadan A. Pharmacokinetics of tilmicosin in serum and milk of goats. Res Vet Sci 1997: 62; 48-50. 15. Rui P, Shen J, Li J, et al. The Pharmacokinetics of Tilmicosin administrated Intravenously and Subcutaneously in Healthy Sheep. Acta Veterinaria et Zootechnica Sinica 2005: 36; 296-300. 16. Shen J, Li C, Jiang H, et al. Pharmacokinetics of tilmicosin after oral administration in swine. AJVR 2005: 66; 1071-4. 17. Tountain PL, Koritz GD. Veterinary drug bioequivalence determination. J. Vet Pharmacol Therap 1997; 20: 79-90. 18. Zhang J, Li J, Miao X, et al. Pharmacokinetics of Tilmicosin in Sheep. Acta Veterinaria et Zootechnica Sinica 2004: 35; 560-4.
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Details

Primary Language English
Subjects Clinical Sciences
Journal Section Research Article
Authors

Elif Şahin

Murat Yıldırım This is me

Publication Date April 30, 2019
Submission Date February 18, 2019
Published in Issue Year 2019 Volume: 9 Issue: 1

Cite

Vancouver Şahin E, Yıldırım M. Bioequivalence in the Sheep of Two Tilmicosin Preparations. Experimed. 2019;9(1):28-31.