Chlorhexidine Digluconate Formulations Used for Skin Antisepsis

Aims: The representativeness of European standards phase 2, step 1 regarding bactericidal and yeasticidal activities was used for the comparison of two marketed antiseptic solutions, one containing chlorhexidine digluconate (0.5%) and the other combining chlorhexidine digluconate (0.25%), benzalkonium chloride (0.025%) and benzylic alcohol (4%). Methods: The bactericidal activity of the antiseptic solutions used pure or diluted was assessed according to the European standards NF EN 13727 and NF EN 13624 for the bactericidal and yeasticidal activity respectively. The contact time was 1 min at 20°C. Interfering substances used correspond to soiling conditions i.e. bovine serum albumin and sheep erythrocytes. A reduction of colony-forming units by ≥5 log10 was deemed to meet the requirements to conclude bactericidal activity and ≥4 log10 for yeasticidal activity. Results: Regarding all the mandatory strains, both solutions are bactericidal and yeasticidal even after a 40% dilution and even under “dirty” conditions. Conclusions: The present study demonstrated the efficient bactericidal and yeasticidal activity of aqueous solutions containing chlorhexidine digluconate either alone at a concentration of 0.5% (w/v) or at a concentration of 0.25% (w/v) when combined with benzalkonium chloride at 0.025% (w/v) and benzylic alcohol 4%. These results have to be considered regarding the respective formulations and potent allergy risks.