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Submitted: 05 Jun 2025
Revision: 28 Jul 2025
Accepted: 02 Aug 2025
ePublished: 11 Oct 2025
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Pharm Sci. 2025;31(4): 440-451.
doi: 10.34172/PS.025.42799
  Abstract View: 31
  PDF Download: 46

Research Article

Preparation, Pharmaceutical Characterization, In-Vitro Release Kinetics, and Antifungal Efficacy Investigation of Fluconazole Niosomal Hydrogel

Mohammad Amin Raeisi Estabragh 1,2* ORCID logo, Hossein Pardakhty 3, Abbas Pardakhty 4* ORCID logo

1 Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran
2 Department of Pharmaceutics, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran
3 Faculty of Veterinary, Islamic Azad University, Karaj, Iran
4 Pharmaceutics Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran
*Corresponding Authors: Mohammad Amin Raeisi Estabragh, Email: a.raeisi@kmu.ac.ir, Email: aminr374@yahoo.com; Abbas Pardakhty, Email: abpardakhty@kmu.ac.ir, Email: drpardakhti@yahoo.com

Abstract

Background: Lipid vesicular systems can enhance the penetration of antifungal drugs like fluconazole in topical applications. Niosomes, composed of non-ionic surfactants and cholesterol, are a key type of lipid vesicles.

Methods: Fluconazole (FL) niosomes were prepared using thin film hydration with varying ratios of Span®/Tween®/cholesterol. Their morphological characteristics, particle size, physical stability, encapsulation efficiency (EE%), cumulative drug release, and kinetics were assessed. The optimal formulation was then combined with a gel base, and its physicochemical and pharmaceutical properties were examined. Antifungal efficacy against Candida albicans (ATCC: 10231) was evaluated compared to free drug solutions.

Results: All formulations exhibited encapsulation efficiencies over 50%, with the Span60/Tween60/cholesterol blend (45/45/10 mole%) achieving the highest efficiency (70.2%). Following the Higuchi model, this formulation released 55.4% of FL over four hours. The gel formulations showed good physical stability, particularly the one with 1% carboxymethyl cellulose, which was suitable for topical application due to its pseudoplastic and thixotropic properties. In-vitro minimum inhibitory concentration (MIC) values against Candida albicans were recorded as 16 μg/mL (solution), 2 μg/mL (niosomal suspension), and 4 μg/mL (niosomal gel).

Conclusion: A stable and locally applicable FL niosomal gel can be formulated, potentially enhancing effectiveness and reducing microbial resistance to FL as indicated by antifungal activity results in-vitro.


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