Diclofenac-Loaded Orodispersible Nanofibers Prepared by Double-Needle Electrospinning.

The main aim of this study was to develop a diclofenac-loaded, orodispersible formulation prepared by double-needle electrospinning. For the use of two needles, one above the other, a new needle holder was designed and 3D printed. During the optimization of the drug-free PVP carrier, the effect of the polymer concentration on the morphology and average fiber diameter was investigated. Electrospinning was possible for solutions with a PVP concentration between 7.5 and 15 w/w%. Too low viscosity led to smooth-surfaced nanoparticles, since electrospraying occurred. The optimal material properties and process parameters were used to prepare drug-loaded nanofibers. The morphology, crystallinity, chemical interactions, encapsulation efficiency, drug distribution, in vitro disintegration, in vitro dissolution, cytocompatibility, and 6-month stability were tested. According to the results, the electrospun formulation was an amorphous solid dispersion with excellent encapsulation efficiency. The drug distribution was homogeneous within the nanofiber matrix. The disintegration was completed in about 5 s in artificial saliva and about 41 s on an artificial tongue. The dissolution in artificial saliva was complete within 10 min. Overall, a promising formulation was developed with rapid disintegration, immediate drug release, and good stability. Additionally, a new in vitro dissolution method ("AS-to-FaSSGF") was developed to obtain a bigger picture of drug dissolution throughout the gastrointestinal tract.