Therapeutic and biopharmaceutical assessment of indapamide medications
Abstract
The paper is focussed on the drug release comparison for multisource indapamide medications against the original medication, Arifon retard (1,5 mg; Servier Laboratories, France). The comparative test of dissolution kinetics was performed in three media modelling physiological gastrointestinal conditions: hydrochloric acid solution, pH 1,2; acetate buffer, pH 4,3; and phosphate buffer, pH 6,8. The results of the dissolution kinetics test were compared to those from the comparative therapeutic studies of indapamide medications.
About the Authors
G. V. Ramenskaya
I.M. Sechenov First Moscow State Medical University
Russian Federation
Moscow
Russian Federation
Moscow
S. V. Nedogoda
Volgograd State Medical University
Russian Federation
Volgograd
Russian Federation
Volgograd
I. E. Shokhin
I.M. Sechenov First Moscow State Medical University
Russian Federation
Moscow
Russian Federation
Moscow
A. Yu. Savchenko
I.M. Sechenov First Moscow State Medical University
Russian Federation
Moscow
Russian Federation
Moscow
V. S. Shlykov
I.M. Sechenov First Moscow State Medical University
Russian Federation
Moscow
Russian Federation
Moscow
References
1. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No 937, 40 th Report, Annex 8 of WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization (WHO) 2006.
2. Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm Res 1998; 15(1): 11-22.
3. Раменская Г.В., Шохин И.Е., Давыдова К.С., Савченко А.Ю. In vivo – in vitro корреляция (IVIVC): современный инструмент для оценки поведения лекарственных форм в условиях in vivo.Мед Альм. Нижний Новгород 2011; 14(1): 222-6.
4. База данных ФГБУ «НЦ ЭСМП» Минздравсоцразвития России. URL: http://www.regmed.ru. Проверено: 1 октября 2011.
5. Методические рекомендации для разработчиков и производителей лекарственных средств по изучению сравнительной кинетики растворения генерических лекарственных средств (Утв. Росздравнадзором, 2010). М., ООО «Издательство «Ремедиум» 2010. 24 с.
6. Недогода С.В., Марченко И.В., Чаляби Т.А., Брель У.А. Влияние различных генериков индапамида на суррогатные точки при лечении артериальной гипертензии у лиц пожилого возраста. Сердце 2007; 6(3): 1-4.
7. Карпов Ю.А., Недогода С.В, Кисляк О.А., Деев А.Д.. Основные результаты программы ОРИГИНАЛ. Кардиология 2011; 3: 38-43.
Review
For citations:
Ramenskaya G.V., Nedogoda S.V., Shokhin I.E., Savchenko A.Yu., Shlykov V.S. Therapeutic and biopharmaceutical assessment of indapamide medications. Cardiovascular Therapy and Prevention. 2011;10(8):98-102. (In Russ.)
Views:
573
Email this article 
