Oral fast-dissolving risperidone loaded electrospun nanofiber drug delivery systems for antipsychotic therapy

Risperidone is an antipsychotic drug classified as BCS Class II with low solubility at physiological pH and orally used in the treatment of schizophrenia. Electrospinning is one of the newest fabrication methods used for the development of fast soluble drug delivery systems. In this study, an orally disintegrating film (ODF) formulation of risperidone was developed with green electrospinning technique. Different molecular weight polyethylene oxide (PEO) as a polymer and xylitol or Kollidon VA64 as a disintegration agent were used for the preparation of formulations. Differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR) analyses were conducted as part of pre-formulation studies to identify possible incompatibilities in formulation components. We characterized ODFs based on their mechanical properties, shape and diameter of nanofibers, disintegration behavior, and in vitro dissolution profiles. A few wrinkles appeared on the surface of fibers prepared with xylitol, but a smooth surface was evident on Kollidon VA64 fibers. Disintegration studies performed in the simulated oral environment showed that ODFs disintegrate in as little as 1 s. The dissolution behavior of developed ODFs and commercial products was compared with a dissolution study in distilled water. The chosen formulations had acceptable mechanical properties with much faster dissolution compared to the commercially available product. In this study, risperidone ODF formulation was successfully produced and characterized. The study showed that risperidone-loaded nanofibers could provide a promising alternative to conventional oral dosage forms like tablets and capsules.