The biopharmaceutical studies of Valavir film-coated tablets, 0.5 g
Keywords:biopharmaceutical studies, bioavailability, bioequivalence, test drug product, reference drug product, Valavir 0.5 g film-coated tablets
AbstractThe 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).
Государственная фармакопея Украины / Государственное предприятие «Научно-экспертный фармакопейный центр». – Х.: РІРЕГ, 2001. – 556 с.
Гуреєва С.М. // Укр. журн. лабораторної та клін. медицини. – 2012. – Т. 7, №3. – С. 6-10.
Гуреєва С.М., Заїдзе А.В. Стельмах А.М., Яковенко О.М. // Фармац. часопис. – 2011. – №4(20). – С. 68-72.
Amini H., Javan M., Gazerani P. et al. // Clin. Drug Invest. – 2008. – Vol. 28(1). –P. 47-53.
Rajni Bala, Pravin Pawar, Sushil Khanna et al. // Intern. J. of Pharmac. Investigation. – 2013. – Vol. 3, Iss. 2. – P. 67-76.
Zhang Zhi-Rong, He Qin // World J. of Gastroenterol. (WJG). – 1999. – August. – Vol. 5(4). – P. 330-333.
Copyright (c) 2015 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).