STUDY OF BIOEQUIVALENCE OF 6.25 MG TABLETS OF CARVEDILOL BY SOLUBILITY TEST IN VITRO
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Kunchulia, L., Baramidze, K., Koberidze, N., Tepnadze, L., & Kacharava, M. (2019). STUDY OF BIOEQUIVALENCE OF 6.25 MG TABLETS OF CARVEDILOL BY SOLUBILITY TEST IN VITRO. Collection of Scientific Works of Tbilisi State Medical University, 51, 77–79. https://doi.org/10.52340/csw.2017.51.77-79

Abstract

In vitro bioequivalence of carvedilol-containing ‘’Carvidil’’ 6.25 mg tablets (‘’Grindex’’- Latvia) by correlation of reference drug ‘’Dilatrend’’ 6,25mg tablets (‘’Roche’’- Romania) have been studied by test of solubility. Their standardization according to USP was established. They are pharmaceutically equivalent. The kinetics of solubility of active compound carvedilol in 6,25 tablets of ‘’Carvidil’’ and ‘’Dilatrend’’ have been studied by us at pH 1,45, pH 4,5 and pH 6,8. There was not statistically credible difference. The results of our Biowaiver research correspond to the international protocol of validation Guidance for Bioanalitical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation Research (CDER) Center for Veterinary Medicine (CVM) May 2001. The generic drug ‘’Carvidil’’ and reference drug ‘’Dilatrend’’ are equivalent in vitro.  

https://doi.org/10.52340/csw.2017.51..77-79
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References

1. 1. Бертрам Г. Катцунг. Базисная и клиническая фармакология Т1 2007.
2. Бамбишева Е. И; Толлыгина С. Н; Гуранда Д.Ф; Колтунов И.Е. Клиническая фармакокине¬тическая эквивалентность оригинального и дженерического препарата карведилола у больных ар¬териальной гипертонией 1-2-й степени. Рацио¬нальная фармакотерапия в Кардиологии 2018; N3.
3. Красных Л.М; Савченко А.Ю; Раменская Г.В; Кукес В. Г. Определение относительной био¬доступности и биоэквивалентности препаратов карведилола ведикардола и Дилатрента. Ж. Кардиология; Трудный пациент спецвыпуск 2006.
4. Метелица В.И. Справочник по клинической
фармакологии сердечно-сосудистых лекарс¬
твенных средств. М.: Медицинское информа¬ционное агенство; 2005.
5. Оранов Р. Г.ж., Кухарчук В.В., Бритов А. Н. Комитет зкспертов ВОЗ. Борьба с артериальной гипертонией. Женева, 1996.
6. Шохин И.Е.; Савяненко Г. В.; Васнленко Г.Ф.; Малашенко Е.А. Оценка возможности замены исследования биоэквивальентности in vivo на изу¬чение сравнительной кинетики растворения in vitro (процедура Биовейвер при определении вза¬имозаменяемости лекарственных средств (джене¬риков). Химико-фармацевтическийи журнал. Том 45, N2, 2011.
7. Guidance for Industry. Immediate Release Solid Oral Dosage Forms Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. FDA/Center for Drug Evaluation and Research (CDER), November, 1995,CMC 5.
8. HHS/FDA Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products – general considerations. Rockville, MD, 388
9. Joint Statmenet between The International Pharmaceutical Federation (FIP) and the International Federational of Pharmaceutical Manufactures Associations (IFPMA): Ensuring Quality and Safety of Medicinal Products to Protect the Patient. Geneva: FIP, IFPMA, 2002.
10. Makotosekimoto, Torutakamori, Sakiamori, Sakinakamura, and Masatotaguchi. In vitro Enhancement of Carvedilol Clucuronidation by Amiodarone -Mediated Altered Protein Binding in Incubation Mixture of Human Liver Microsomes with Bovine Serum Albumin. Biol. pharm. bull 39.1359-1363 (2016).
11. WHO Technical Report Series, No. 937, 2006, app. N7.

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