Objective: The objective of the present study was to design a topical gel based on nanoemulsion of Terbinafine HCl, a poorly soluble drug, to increase its permeability and evaluate its effectiveness in an animal model. Materials and methods: Nanoemulsions were incorporated into gels and designated as Gel-P and Gel-S, respectively. The nanoemulsion gel was prepared using liquid paraffin, glycerin and carbomer 940. The nanoemulsions were prepared by two different techniques viz. high pressure homogenization and high speed homogenization. The developed gels were evaluated for drug content, spreadability, microbial testing and in vitro permeation using pig skin. The in vivo antifungal efficacy of the developed gels was evaluated in albino Wistar rats. Results and discussion: The globule size obtained by high-pressure homogenization was less than 2 r.nm (nanometer in radius), and that by high-speed homogenization was less than 10 r.nm. In vitro permeation studies revealed that Gel-P (51.19±0.81%) had higher permeation than Gel-S (31.72±1.12%) and the marketed cream (19.78± 1.01%), essential for the treatment of topical fungal diseases. In vivo antifungal studies in Wistar rats infected with Trichophyton mentagrophytes revealed that topical application of Gel P and Gel S cured the infection within 3 days compared to 14 days for the marketed cream. Conclusion: This study confirms that nanoemulsified gels provided enhanced permeation followed by cure rates of poorly soluble Terbinafine HCl in the animal model and therefore these systems could be the preferred drug carriers for drugs intended for topical use to overcome permeability issues and effectiveness. Keywords: Terbinafine HCl, nanoemulsion gel, permeability, poorly soluble drug, topical antifungal, Trich...... half of the article....... In the case of topical administration, poor permeability of the drug leads to prolonged therapy, thus contributing to increasing the costs of therapy and decreasing patient compliance. One of the approaches to overcome such problems is the administration of lipid-based submicron colloidal drugs. This technology allows a high concentration of drug to penetrate the skin as the skin's lipophilic intercellular pathway allows materials smaller than 20 nm [1] and to functionally create a drug depot in the stratum corneum and epidermis. Therefore, the present study refers to the development of a NE incorporated into a gel vehicle without affecting its physicochemical properties and stability. Therefore, the objective of the present study was to develop a sub-micron drug delivery system, namely nanoemulsion gel (NE gel) for TFH to increase its permeability, in order to accentuate its therapeutic efficacy.
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