The aim of this research was to investigate the stability of a lidocaine-loaded nanostructured\nlipid carrier dispersion at different temperatures, formulate a nanostructured lipid carrier gel, and test\nthe penetration profile of lidocaine from the nanostructured lipid carrier gel using different skin\npenetration modeling methods. The formulations were characterized by laser diffraction, rheological\nmeasurements and microscopic examinations. Various in vitro methods were used to study drug\nrelease, diffusion and penetration. Two types of vertical Franz diffusion cells with three different\nmembranes, including cellulose, Strat-M®, and heat separated human epidermis were used and\ncompared to the Skin-parallel artificial membrane permeability assay (PAMPA) method. Results\nindicated that the nanostructured lipid carrier dispersion had to be gelified as soon as possible for\nproper stability. Both the Skin-PAMPA model and Strat-M® membranes correlated favorably with\nheat separated human epidermis in this research, with the Strat-M® membranes sharing the most\nsimilar drug permeability profile to an ex vivo human skin model. Our experimental findings suggest\nthat even when the best available in vitro experiment is selected for modeling human skin penetration\nto study nanostructured lipid carrier gel systems, relevant in vitro/in vivo correlation should be made\nto calculate the drug release/permeation in vivo. Future investigations in this field are still needed to\ndemonstrate the influence of membranes and equipment from other classes on other drug candidates.
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