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

• Published in: Biological & pharmaceutical bulletin Vol. 45; no. 2; pp. 220 - 225
• Main Authors: Nishioka, Hisae, Shiozaki, Mari, Nii, Takuya, Hayashi, Nahoki, Hagi, Akifumi
• Format: Journal Article
• Language: English
• Published: Japan The Pharmaceutical Society of Japan 01.02.2022; Japan Science and Technology Agency
• Subjects: Adhesiveness; Animals; Anti-Infective Agents, Local - administration & dosage; Antimicrobial activity; Antimicrobial agents; antiseptic; Azo Compounds - administration & dosage; Bacteria - drug effects; Bacteria - growth & development; Biguanides - administration & dosage; Drug Compounding; ex vivo skin model; Female; Food Coloring Agents - administration & dosage; Fungicidal activity; Glucuronates - administration & dosage; Iodine; olanexidine; peel test; persistence; Povidone; Skin - drug effects; Skin - microbiology; Skin tests; Surgical site infections; Swine; Vancomycin; antiseptic; persistence; antimicrobial activity; ex vivo skin model; olanexidine; peel test
• ISSN: 0918-6158; 1347-5215
• DOI: 10.1248/bpb.b21-00833

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.