Journal of Pharmaceutical and Allied Sciences

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Physicochemical and safety characteristics of novel microstructured lipid-based drug delivery system encapsulating miconazole nitrate

F.C. Kenechukwu, A.A. Attama, E.C. Ibezim, L.I. Nweke, J.E. Ahiabuike


This study was designed to investigate an intravaginal drug delivery system based on biocompatible phytolipids [Softisan® 154 (SF) (hydrogenated palm oil) and super-refined sunseed oil (SO)] and polyethylene glycol (PEG)-4000 for improved physicochemical performance and safe delivery of miconazole nitrate (MN). Lipid matrices (LMs) consisting of optimized 1:9 blend of SO and SF with increasing amounts of PEG-4000 (0, 10, 20, 40 % w/w) were employed to formulate MN-loaded solid lipid microparticles (SLMs) by melt-homogenization. The SLMs were evaluated in terms of encapsulation efficiency (EE), loading capacity (LC), particle size, morphology, tolerability in female rabbits and stability. Results showed that SLMs based on SO:SF (1:9) and PEG-4000 (40 %w/w) gave highest EE (88.05%) and LC (25.00 g of MN per 100 g of lipid). This optimized formulation (DM) had the least particle size, mostly spherical microparticles. Moreover, the formulation was stable and histopathologically safe. This study has shown that the developed microstructured lipid-based formulation could be employed for improved physicochemical performance and safe intravaginal delivery of miconazole nitrate.

Keywords: Miconazole nitrate, Softisan® 154, Intravaginal drug delivery, Physicochemical performance, vaginal tolerance test (VTT), Biocompatible phytolipids

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