The pharmaceutical equivalence of Zantac (reference drug) and 10 domestic and foreign generics of ranitidine hydrochloride as 150-mg coated tablets has been studied using the pharmacopoeic (USP 29) dissolution test. Analyses showed insignificant differences in the excipients entering into the compositions of ranitidine generic tablets registered in Russia. It is established that Zantac and generics of two manufacturers are rapidly soluble (according to the WHO classification). Analysis of the similarity coefficients determined for the dissolution profiles measured in media with different pH values showed the biological nonequivalence of some generics and the reference drug. It is demonstrated that the in vitro dissolution test recommended by WHO can be used for determining the bioequivalence of ranitidine generics.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 43, No. 11, pp. 44 – 48, November, 2009.
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Smekhova, I.E., Moldaver, B.L. & Perova, Y.M. Equivalence of ranitidine generic tablets studied using the in vitro dissolution test. Pharm Chem J 43, 632–636 (2009). https://doi.org/10.1007/s11094-010-0368-y
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DOI: https://doi.org/10.1007/s11094-010-0368-y