Resumo

URQUIZA GAVIDIA, Danitza Iraiz; VALENCIA ALAYO, Karen Edith Merari de los Santos; CASTILLO SAAVEDRA, Ericson Felix  e  AYALA JARA, Carmen Isolina. In vitro biosimilarity of ranitidine 300 mg tablets dispensed in peruvian settlers. Rev Cub Quim [online]. 2019, vol.31, n.2, pp.199-208. ISSN 2224-5421.

The study was aimed at determining the in vitro biosimilarity of ranitidine 300 mg multi-source tablets and reference that are prescribed and dispensed in Peruvian residents. Twelve tablets from two laboratories (multi-source and reference) were used, which were analyzed in three dissolution media with buffer pH 1.2; 4.5 and 6.8; to get the amount of medication dissolved as a function of time. The results for the means of dissolution indicate that the data were adjusted to the order kinetic model, the statistical treatment for the mean time of dissolution and dissolution efficiency by student t showed that there is no significant difference between the multi-source drug and the reference. The values of the similarity factor f2 were 83,3; 75,8 and 71,1 for the pH 1,2; 4,5 and 6,8 respectively. Biological similarity between the multi-source drug and the reference based on in vitro dissolution tests is concluded.

Palavras-chave : similarity; biological; ranitidine; multi-source; referent.

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