Pharmaceutical Properties of a Tinted Formulation of a Biguanide Antiseptic Agent, Olanexidine Gluconate

Biol Pharm Bull. 2022 Feb 1;45(2):220-225. doi: 10.1248/bpb.b21-00833. Epub 2021 Nov 25.

Abstract

Olanexidine gluconate-containing preoperative antiseptic (OLG-C) is colorless, which makes it difficult to determine its area of application. To overcome this drawback, we realized a stable orange-tinted antiseptic (OLG-T) by adding new additives to OLG-C and investigated its pharmaceutical properties compared with OLG-C and povidone iodine (PVP-I). We evaluated the influence of the additives on the antimicrobial activity and adhesiveness of medical adhesives to OLG-T-applied skin by in vitro time-kill/ex vivo micropig skin assays and a peel test using excised micropig skin, respectively. In the in vitro time-kill assay, the bactericidal/fungicidal activity of OLG-T and OLG-C were equivalent. In the ex vivo micropig skin assay, their fast-acting and persistent bactericidal activities against vancomycin-resistant Enterococcus faecalis were higher than that of PVP-I. In the peel test, the adhesion force of the incise drape and the amount of stripped corneocytes on the peeled drape were comparable between OLG-T- and OLG-C-applied skin, but both were less than those of PVP-I-applied skin. The drapes for OLG-T- and OLG-C-applied skin had moderate adhesion force, and the drape-related injuries were expected to be weak. These results suggest that OLG-T performs no worse than OLG-C in terms of its antimicrobial activity and medical adhesive compatibility. Therefore, we expect OLG-T to lead to more convenient preoperative skin preparation and further contribute to lowering surgical site infection rates.

Keywords: antimicrobial activity; antiseptic; ex vivo skin model; olanexidine; peel test; persistence.

MeSH terms

  • Adhesiveness
  • Animals
  • Anti-Infective Agents, Local / administration & dosage*
  • Azo Compounds / administration & dosage*
  • Bacteria / drug effects*
  • Bacteria / growth & development
  • Biguanides / administration & dosage*
  • Drug Compounding
  • Female
  • Food Coloring Agents / administration & dosage*
  • Glucuronates / administration & dosage*
  • Skin / drug effects*
  • Skin / microbiology
  • Swine

Substances

  • Anti-Infective Agents, Local
  • Azo Compounds
  • Biguanides
  • Food Coloring Agents
  • Glucuronates
  • 6-hydroxy-5-((p- sulfophenyl)azo)-2-naphthalenesulfonic acid disodium salt
  • olanexidine gluconate