Abstract

MARTINEZ, Laura A.; SANABRIA, Lina M.  and  BAENA, Yolima. Safety assessment of complex benzoic acid using in vitro permeation assays with pig skin in Franz cells. Rev. colomb. cienc. quim. farm. [online]. 2020, vol.49, n.2, pp.291-305.  Epub Nov 25, 2020. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v49n2.88988.

Franz cells are one of the main tools to evaluate the transepithelial permeation of compounds through the performance of in vitro tests, these allows inferring the safety behavior of a compound in the skin. The objective of this research was to determine the permeation behavior of benzoic acid from complexes with polyelectrolytes (EuB 75 Cl 25 EuB 100), compared to benzoic acid without complexing, to infer its safety behavior. In a first phase, skin storage conditions were established comparatively evaluating the diffusion parameters (flow and permeation constant) and transepithelial water loss, using ears skin of freshly slaughtered pigs, stored in 1M NaCl at -2 °C for 3 days; it was worked under infinite doses conditions. Subsequently, the permeation test of two complexes between Eudragit E and benzoic acid, in comparison with benzoic acid, was carried out under finite dose conditions. The benzoic acid quantification was performed with an analytical method validated by HPLC-DAD. The results showed no significant differences showing that biological samples can be stored for 72 h under the conditions described. The permeation behavior of the complexed benzoic acid with respect to the free benzoic acid showed a better safety profile, since there was a lower permeation for the first case. These results show that complexation of benzoic acid could decrease the sensitivity reactions that it normally presents, based on the decrease in its permeation.

Keywords : Franz cells; preservatives; benzoic acid; complexes; skin; security.

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