Development And In Vitro Evaluation Of A Polymer-Based Topical Film-Forming Spray Incorporating Octenidine Dihydrochloride And Benzalkonium Chloride For Advanced Antiseptic Applications

Abstract

Background:
Skin and soft tissue infections (SSTIs) remain a major clinical concern due to increasing antimicrobial resistance and limitations of traditional antiseptic formulations. Film-forming sprays (FFSs) present a promising alternative for topical drug delivery, offering sustained antimicrobial protection and ease of use.

Objective:
This study aimed to develop and evaluate a polymer-based film-forming spray incorporating Octenidine Dihydrochloride and Benzalkonium Chloride for advanced antiseptic application, targeting enhanced skin adhesion, prolonged release, and broad-spectrum antimicrobial coverage.

Methods:
Preformulation studies confirmed solubility, compatibility, and partition characteristics of the active ingredients. Nine formulations (F1–F9) were prepared using varying concentrations of polyvinyl alcohol (PVA), glycerin, and ethanol:IPA ratios, and evaluated for physical properties, drug content, and in-vitro drug release. The optimized formulation (F6) was assessed for drug release kinetics using Franz diffusion and mathematical modeling.

Results:
Formulation F6, comprising 4% PVA and 3% glycerin in an 80:20 ethanol:IPA solvent system, demonstrated optimal mechanical strength (0.72 N/mm²), uniform drug content (98.6%), fast drying (95 seconds), and highest cumulative drug release (99.5% at 24 hours). Kinetic analysis revealed first-order release (R² = 0.9883), indicating concentration-dependent diffusion from the polymer matrix.

Conclusion:
The developed film-forming spray successfully addressed limitations of conventional antiseptics by combining ease of application, film durability, and sustained release. This delivery system holds strong potential for advanced wound care, surgical site prophylaxis, and outpatient antiseptic therapy.