The biopharmaceutical studies of Valavir film-coated tablets, 0.5 g

Authors

  • S. N. Gureyeva JSC "Farmak", Ukraine
  • A. M. Goy JSC "Farmak", Ukraine
  • Ju. A. Kondratova JSC "Farmak", Ukraine
  • E. G. Oksamytna JSC "Farmak", Ukraine

DOI:

https://doi.org/10.24959/nphj.15.2069

Keywords:

biopharmaceutical studies, bioavailability, bioequivalence, test drug product, reference drug product, Valavir 0.5 g film-coated tablets

Abstract

The biopharmaceutical studies of Valavir film-coated tablets, 0.5 g, with valaciclovir hydrochloride have been substantiated in the article. The biopharmaceutical studies have been conducted in vitro; the dissolution profiles of Valavir film-coated tablets, 0.5 g, and the reference drug Valtrex (film-coated tablets, 500 mg, manufactured by GlaxoSmithKline Pharmaceuticals S.A., Poland) have been compared by the method for Dissolution Kinetics. The results of the experimental study in vivo, namely the value of Cmax, AUC0-t and other values confirm that Valavir film-coated tablets, 0.5 g, manufactured by Farmak JSC is bioequivalent to the reference drug Valtrex film-coated tablets, 500 mg, (GlaxoSmithKline Pharmaceuticals S.A., Poland).

Author Biographies

S. N. Gureyeva, JSC "Farmak"

Head of Central laboratory pharmaceutical development

A. M. Goy, JSC "Farmak"

Руководитель департамента исследований и разработки

Ju. A. Kondratova, JSC "Farmak"

Начальник аналитической лаборатории Центральной лаборатории фармацевтической разработки

 

E. G. Oksamytna, JSC "Farmak"

Начальник отдела медицинского и фармакологического менеджмента

References

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Published

2015-12-02

Issue

Section

Technology of Medicines