Introduction: Topical ketoprofen formulations provide localized analgesic and anti-inflammatory effects while reducing systemic adverse events associated with oral administration. Franz diffusion cells, are widely used to evaluate the permeation and dissolution rate of active pharmaceutical ingredient in topical formulations.Aim: The aim of this study was to perform macroscopic and microscopic analysis of ketoprofen gel formulations available in the Republic of Serbia, to examine the in vitro release rate using 3D printed Franz cells, as well as to analyze the influence of the type of receptor medium on the release rate of ketoprofen.Material and Method: Two ketoprofen gel formulations were examined. Macroscopic and microscopic analysis were performed under normal and polarized light. Ketoprofen content was determined by UV/VIS spectrophotometry. In vitro release studies were carried out using 3D-printed Franz diffusion cells with synthetic membranes as diffusion barriers. Phosphate buffer pH 7.4 and 70% (v/v) ethanol were used as receptor media.Results: Both ketoprofen gels were transparent, and exhibited similar gloss. Formulation A demonstrated lower structural integrity and stickiness than Formulation B. The ketoprofen in both formulations was within ± 5% of the declared value. In vitro release test showed that Formulation A exhibited a faster release of ketoprofen compared to Formulation B in both phosphate buffer and ethanol. Formulation B had lower spreadability comparing to Formulation A.Conclusion: These results highlight the potential of 3D printed Franz diffusion cells in future for in vitro evaluation of authorized topical formulations in the Republic of Serbia, where different receptor media can be used, which further allows better comparison of formulations under different experimental conditions.
Ćoškov et al. (Thu,) studied this question.