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Development and Study of Hydrophilic Ointment Compositions with a Dextrin/Polyvinyl Alcohol/Iodine Complex (D/PVA/I)
Zhassur Taganov1, Anel Azamatova1, Roza Karzhaubayeva1
1Scientific Center for Anti-Infectious Drugs JSC, Almaty 050060, Kazakhstan.
Abstract:
Background: Iodine-based antimicrobial systems remain highly attractive due to their broad-spectrum activity; however, the clinical application of free iodine is limited by its instability and cytotoxicity. This study aimed to develop polyethylene glycol (PEG)-based hydrophilic ointment formulations containing a dextrin/polyvinyl alcohol/iodine complex (D/PVA/I) and to evaluate their physicochemical properties, antimicrobial activity, and cytotoxicity. Methods: Hydrophilic ointment formulations containing 2.5%, 5.0%, and 10.0% D/PVA/I were prepared using a PEG-based matrix composed of PEG 4000, PEG 400, and glycerol. Physicochemical characterization included organoleptic evaluation, pH measurement, rheological analysis, and UV-visible (Ultraviolet-visible) spectroscopy. Antimicrobial activity was assessed using agar diffusion and minimum bactericidal concentration (MBC) assays against Staphylococcus aureus, Escherichia coli, Enterococcus hirae, and Pseudomonas aeruginosa. Cytotoxicity was evaluated in Madin-Darby Canine Kidney (MDCK) cells using the MTT assay. Results: All formulations exhibited homogeneous semisolid structure and physiologically acceptable pH values (4.94-5.45). Rheological analysis demonstrated non-Newtonian pseudoplastic (shear-thinning) behavior. The flow behavior index (n) ranged from 0.03 to 0.33 according to the Ostwald-de Waele model, confirming shear-thinning characteristics, while viscosity increased with increasing D/PVA/I concentration. UV-visible spectroscopy confirmed the presence of triiodide ions (I3-), characterized by absorption maxima at approximately 287 and 350 nm, indicating preservation of active iodine species within the PEG matrix, while placebo (blank) formulation analysis confirmed the absence of corresponding absorption bands, demonstrating that the PEG-based matrix does not contribute to the characteristic spectral features. The formulations demonstrated broad-spectrum antimicrobial activity, with MBC values ranging from 0.01 to 0.02 µg/mL. Cytotoxicity studies revealed moderate toxicity of the D/PVA/I complex (CC50 = 0.82%) (50% cytotoxic concentration (CC50) and significantly lower toxicity of the PEG-based ointment base (CC50 = 18.38%). Conclusions: The developed PEG-based hydrophilic ointment formulations containing the D/PVA/I complex demonstrated favorable physicochemical characteristics, stability of iodine species, pronounced antimicrobial activity, and acceptable cytotoxicity profiles. These findings highlight the potential for the developed systems to be promising topical antimicrobial formulations.
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