Abstract

In this work the approaches to assess of the xymedone release from hydrophilic gels with zinc oxide nanoparticles were proposed using a vertical Franz diffusion cell at 37 ℃. A partial validation protocol included the varying of the membrane polarity (lipophilic or hydrophilic cellulose acetate), the acceptor chamber volume (4,35 mL or 12,71 mL), the gel composition (with or without zinc oxide nanoparticles), as well as the metrological characteristics for the xymedone assay when it was released through the membrane in a Franz cell. It was estimated that the Franz cell with the volume of 12,71 mL, and the lipophilic membrane made it possible to estimate the amount of xymedone released with less error (RSD no more than 2%). We showed that the xymedone immobilization into zinc oxide nanoparticles increased the efficiency of xymedone release from the hydrophilic gel by 30%. The xymedone release through the both hydrophilic and lipophilic membranes is described by a pseudo-second-order equation that typical for desorption process from the polymer matrix. The proposed partial validation protocol to assessing the drug release using the Franz cell can be useful for selection of optimal composition of dermal topical dosage forms with hydrophilic pharmaceutical active substances. Keywords: hydrogels, release, xymedone, zinc oxide nanoparticles, partial validation protocol

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