Development Of Colored Chlorhexidine-Based Topical Antiseptic Solutions: Formulation Optimization And In Vitro Characterization Studies


Özcan Kosif K., Şişman E., Ağın F., Demir S., Aliyazıoğlu Y., Yılmaz G.

EUFEPS - SITELF MEETING, NAPLES 2026, Naples, İtalya, 27 - 29 Mayıs 2026, ss.1, (Özet Bildiri)

  • Yayın Türü: Bildiri / Özet Bildiri
  • Basıldığı Şehir: Naples
  • Basıldığı Ülke: İtalya
  • Sayfa Sayıları: ss.1
  • Karadeniz Teknik Üniversitesi Adresli: Evet

Özet

Preoperative patient skin antisepsis aims to minimize the risk of surgical site infections

by reducing the microbial load on the skin and eliminating transient microorganisms

present at the surgical site [1]. For this purpose, iodine-based solutions (povidone–

iodine) and chlorhexidine (2.0–2.5%) in alcohol are commonly used. Chlorhexidine binds

to the stratum corneum of the skin and maintains its antimicrobial activity even in the

presence of blood or serum, whereas povidone–iodine may lose its effectiveness in

blood-contaminated environments [2]. In infection control, particularly in surgical site

antisepsis, alcoholic chlorhexidine at concentrations of 2.0–2.5% demonstrates faster,

longer-lasting, and superior antibacterial activity compared with povidone–iodine. [3]

However, insufficient visual clarity of the application area, the limited persistence of the

solution on the skin surface, and the fact that the color of currently available colored

formulations is not considered optimal by clinicians restrict practical use and user control.

This study was designed as a product development project conducted under TÜBİTAK

1005 – National New Ideas and Products Research Support Program, aiming to develop

clinically/field-transferable, visually distinct, skin-compatible, and colored topical

antiseptic solutions containing chlorhexidine.

In the first stage of the study, low-viscosity chlorhexidine solutions containing Allura Red,

Sunset Yellow, and Brilliant Blue dyes at different concentrations were prepared using a

simple mixing method; the formulations were evaluated in terms of physical appearance

and short-term physical stability. To increase the residence time on the application

surface and control the flow behavior, viscous antiseptic solutions were designed in the

second stage, with Polyvinylpyrrolidone (PVP) selected as the viscosity-enhancing

agent. pH and viscosity measurements were performed on formulations prepared with

increasing PVP ratios (1–2%) and low dye concentrations. Selected formulations were

applied to mouse skin to evaluate color deposition and visual marking of the application

area; color intensity and spread were monitored for 60 minutes. In the antimicrobial

efficacy evaluation, the developed antiseptic solution achieved a 99.999% reduction in

microbial load within just 2 minutes of contact time, successfully meeting the reduction

criteria specified in relevant standards for both bacteria and fungi. Additionally,

cytotoxicity tests for the formulations will be performed to further ensure safety.

As a result, two strong product candidates for topical antiseptic solutions have been

developed, featuring optimized pH, viscosity, and color visibility. The high level of

antimicrobial efficacy, favorable short-term stability findings, and distinct visual marking

capacity strongly support the potential for these formulations to be developed as

marketable, product-focused antiseptic solutions for clinical and surgical applications.