Bioequivalence in the Sheep of Two Tilmicosin Preparations

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.

Keywords

• Bioequivalence,sheep,tilmicosin phosphate

İki Tilmikosin Preparatının Koyunlarda Biyoeşdeğerliği

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.

Keywords

• Biyoeşdeğerlik,koyun,tilmikosin fosfat

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