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Comparative evaluation of quality of doxycycline formulations registered in Estonia to those registered in the Russian Federation
Author(s) -
Meos A.,
Paap M.,
Matto V.,
Veski P.
Publication year - 2008
Publication title -
drug development research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.582
H-Index - 60
eISSN - 1098-2299
pISSN - 0272-4391
DOI - 10.1002/ddr.20228
Subject(s) - pharmacopoeia , doxycycline , russian federation , drug , dissolution testing , active ingredient , chemistry , pharmacology , medicine , traditional medicine , business , antibiotics , alternative medicine , biopharmaceutics classification system , biochemistry , pathology , economic policy
The in vitro properties of four Estonian drug market (manufactured in Austria, Germany, and Finland) and four Russian Federation drug market (manufactured in Belarussia and Russian Federation) doxycycline formulations were evaluated using the estimation of the quantitative content and purity of the active pharmaceutical ingredient (API) and the dissolution test. Tolerance limits were set according to the European Pharmacopoeia (for the content and purity of the API) and USP (for the dissolution test) doxycycline monographs. All Estonian drug market doxycycline formulations complied with the tolerance limits in all tests and assays. Most of the Russian Federation drug market doxycycline formulations also passed the tolerance limits, with two minor exceptions: one formulation contained quantitatively API below the USP limit (83.7% instead of the 90%), but all the API was readily released in the dissolution test, the other formulation (capsules) released 80% of API in 39 min instead of 30 min. The general conclusion of the study is that despite some deviations, the Russian Federation drug market doxycycline formulations are comparable with those purchased from the Estonian drug market. Drug Dev Res 69: 58–68, 2008. © 2008 Wiley‐Liss, Inc.