Self nano emulsifying drug delivery system of ketoconazole for topical administration
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Author:
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DAREWIN MENDONSA, MARINA KOLAND, SINDHOOR S M
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Abstract:
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The aim of present study was to prepare a self nano-emulsifying drug delivery system (SNEDDS) of ketoconazole for topical administration. Ketoconazole is an excellent antifungal agent that is useful in treatment of fungal infections due to Candida species, but it is a BCS class II drug and hence has poor water solubility which limits its efficacy. SNEDDS is a system consisting of oil, surfactant and co-surfactant that spontaneously emulsify on dilution. A pseudo-ternary phase diagram was plotted to determine the exact concentration of components to be mixed in order to obtain a stable SNEDDS preconcentrate. The design of experiment was carried out using Design Expert® 7.0 (State-Ease Inc. Minneapolis, USA) software and using a D-optimal design the entire study design was developed. The statistical tool helped in optimization of the formulation and achieving a formula which is most desirable. Particle size analysis and Polydispersity Index depicted that the optimized SNEDDS formulation produced a nanoemulsion upon dilution with a globule size of 13.87 nm and a polydispersity index of 0.086 which indicates high degree of uniformity in globule size. Accelerated stability studies showed that the formulation is able to withstand temperature fluctuations on storage for long durations of time. Antifungal activity showed enhanced performance of the drug compared to standard. In vivo skin irritability studies were performed that indicated that the formulation does not produce any skin irritability and is suitable for topical administration.
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Keyword:
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SNEDDS, Ketoconazole, Pseudo-ternary phase diagram, Design Expert
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EOI:
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DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.352
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