Bioequivalence in the Sheep of Two Tilmicosin Preparations

Year 2019, , 28 - 31, 30.04.2019

Elif Şahin , Murat Yıldırım

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.

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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