Abstract
Fungal skin infections are currently a major clinical problem due to their increased occurrence and drug resistance. The treatment of fungal skin infections is based on monotherapy or polytherapy using the synergy of the therapeutic substances. Tea tree oil (TTO) may be a valuable addition to the traditional antifungal drugs due to its antifungal and anti-inflammatory activity. Ketoconazole (KTZ) is an imidazole antifungal agent commonly used as a treatment for dermatological fungal infections. The use of hydrogels and organogel-based formulations has been increasing for the past few years, due to the easy method of preparation and long-term stability of the product. Therefore, the purpose of this study was to design and characterize different types of Pluronic® F-127 gel formulations containing KTZ and TTO as local delivery systems that can be applied in cases of skin fungal infections. The influence of TTO addition on the textural, rheological, and bioadhesive properties of the designed formulations was examined. Moreover, the in vitro release of KTZ, its permeation through artificial skin, and antifungal activity by the agar diffusion method were performed. It was found that obtained gel formulations were non-Newtonian systems, showing a shear-thinning behaviour and thixotropic properties with adequate textural features such as hardness, compressibility, and adhesiveness. Furthermore, the designed preparations with TTO were characterized by beneficial bioadhesive properties. The presence of TTO improved the penetration and retention of KTZ through the artificial skin membrane and this effect was particularly visible in hydrogel formulation. The developed gels containing TTO can be considered as favourable formulations in terms of drug release and antifungal activity.
Highlights
Topical drug delivery is recognized as an effective method of therapy, which is a desirable feature for the relief of local symptoms at a relatively low dose, reducing systemic side effects
Pluronic® F-127 gels have been widely investigated in the literature as drug carriers because of their low toxicity, reverse thermal gelation, high drug loading capabilities, and ability to gel in the physiological conditions at relatively low polymer concentration [1,2,3]
The formulations intended for use on the surface of skin affected by fungal infection should be characterized by high antimycotic effectiveness, favourable application properties, and good release of the active substance from the vehicle
Summary
Topical drug delivery is recognized as an effective method of therapy, which is a desirable feature for the relief of local symptoms at a relatively low dose, reducing systemic side effects. Pluronic® F-127 (amphiphilic copolymers consisting of units of ethylene oxide and polypropylene oxide) gels have been widely investigated in the literature as drug carriers because of their low toxicity, reverse thermal gelation, high drug loading capabilities, and ability to gel in the physiological conditions at relatively low polymer concentration [1,2,3]. Pluronic lecithin organogel (PLO) is an interesting vehicle owing to its biocompatibility, amphiphilic nature, facilitation of drug dissolution, and its permeation enhancement properties. It is a two-phase system consisting of the oil phase and the water phase. The entangled reverse micelles form a three-dimensional network which entraps the outer continuous nonpolar phase and immobilizes it, turning into a viscous gel by self-association of separate gelator molecules [2,4,5].
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