DISSOLUTION PROFILE STUDIES OF BCS CLASS II DRUG VALSARTAN BY BIOWAIVER PROCEDURE
Abstract
Drug release studies (or in vitro release) of valsartan in three dissolution media simulating the main sections of the gastrointestinal tract were conducted. The concentrations were determined using UV/Vis spectrophotometer (Varian Cary 50) at 254 nm. The study was conducted using dissolution apparatus with the paddle assemble; 5-mL sample aliquots were withdrawn at 5, 10, 15, and 30 min. Estimation f2 parameter confirmed the equivalence of valsartan dissolution kinetics: f2=67 in hydrochloric acid solution, pH 1,2; f2=57 in phosphate buffer, pH 4,5, and in phosphate buffer, pH 6,8 - dissolution amount is greater than 85% at 15 min, so the two products are deemed equivalent, and a profile comparison is not necessary.
About the Authors
E. R. Brigas
M.V. Lomonosov Moscow State University
Russian Federation
Russian Federation
E. V. Uspenskaya
People Friendship University of Russia
Russian Federation
Russian Federation
V. V. Pisarev
Scientific-production center “Probiotech”
Russian Federation
Russian Federation
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Review
For citations:
Brigas E.R., Uspenskaya E.V., Pisarev V.V. DISSOLUTION PROFILE STUDIES OF BCS CLASS II DRUG VALSARTAN BY BIOWAIVER PROCEDURE. Drug development & registration. 2016;(4):152-157. (In Russ.)
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