Improved Rapid Action of Dapoxetine Hydrochloride & L-arginine Solid Dispersion Using Film Formulation

Dapoxetine Hydrochloride (DH) have been developed for the treatment of premature ejaculation for men. DH promotes the ejaculatory delay as the selective serotonin inhibitor. However, it is necessary to delay time about 1–3 hours to absorb drug after oral administration. Therefore, rapid action is needed to reduce DH’s delay time. In this study, after making the Solid Dispersion (SD) with L-arginine (L-A) using rotary evaporation, we made Oral Thin Film (OTF) formulation for the immediately SD’s release. Characterizations of the samples were performed to analyze the morphology, crystallinity, the moecular structure by Scanning Electron Microscopy (SEM), Fourier Transform Infrared Spectroscopy (FTIR) and Powder X-Ray Diffractometer (PXRD). And, thermal porperty was also measured by Differential Scanning Calorimeter (DSC). Then, the dissolution test was used to analyze dissolution rate of the immediately released formulation via Batch (BAT). In this results, OTF is good formulation against the others and the BAT 3 is more dissoluble than other BATs. So, it is useful to cure the premature ejaculation.