Resumen

JUNG COOK, Helgi; ANDA JAUREGUI, Guillermo de; RUBIO CARRASCO, Kenneth  y  MAYET CRUZ, Lourdes. Comparison of dissolution profiles: Impact of criteria of different regulatory agencies on f₂ calculation. Rev. mex. cienc. farm [online]. 2012, vol.43, n.3, pp.67-71. ISSN 1870-0195.

The aim of the present study was to assess the impact of the sampling times and the percentage dissolved on the similarity factor f2. Dissolution results of albendazole, ranitidine, ciprofloxacin and metronidazole previously performed were used. Data were evaluated using the criteria of regulatory agencies such as: a) Food and Drug Administration (FDA), which indicates that for the evaluation of similarity factor only one measurement should be considered after 85% dissolution of both the products and b) European Agency for the Evaluation of Medicinal Products (EMA) which specifies that for the evaluation of the similarity factor not more than one mean value greater than 85% dissolved for any of the formulations should be considered. The results showed that the f2 values were similar when both methods were used; however the test is more rigorous when the EMA criterion is used.

Palabras llave : in vitro release; dissolution profiles; similarity factor ƒ₂.

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