Evaluation of the Drug–Polymer Compatibility and Dissolution Behaviour of Fenbendazole–Soluplus® Solid Dispersions Prepared by Hot-Melt Extrusion

Fenbendazole is an important anti-parasitic medicine widely used in the veterinary field and has recently been considered as a possible anti-cancer agent in humans by some researchers. Fenbendazole encounters challenges in its usage due to its limited aqueous solubility, which consequently impacts its therapeutic efficacy. In this work, an in vitro mechanistic investigation was conducted to evaluate the compatibility, amorphization behaviour and dissolution profile of fenbendazole dispersed in Soluplus^® using the solid dispersion approach via hot-melt extrusion. Three different fenbendazole/Soluplus^® ratios were formulated and characterised through systematic experimentation. Powder X-Ray Diffraction (PXRD), Differential Scanning Calorimetry (DSC), Scanning Electron Microscopy (SEM), Energy Dispersive X-Ray (EDX) and Fourier Transform Infrared Spectroscopy (FTIR) were employed for thermal, physical, chemical and morphological analyses. The solubility of the drug formulation during a dissolution test was investigated using Ultraviolet-Visible (UV-Vis) spectrophotometric measurements. In vitro dissolution testing in acidic and neutral media was employed as a controlled environment to compare dissolution behaviour among different loadings. The extrudates demonstrated markedly enhanced apparent solubility compared to neat fenbendazole, with the 5% formulation showing the highest dissolution rate (approximately 85% after 48 h). This improvement can be attributed to better wetting properties and drug dispersion within the Soluplus^® matrix. This innovative strategy holds promise in surmounting fenbendazole's solubility limitations, presenting a comprehensive solution to enhance its therapeutic effectiveness.