Formulation and characterization of fast dissolving oral films containing buspirone hydrochloride nanoparticles using design of experiment

摘要

This work aims to prepare fast dissolving oral films (FDOFs) containing nanoparticles of buspirone hydrochloride (BH). The concept of this formulation provides the drug delivery system with enhanced bioavailability and sustained release action. These formulations deliver the drug through oral mucosa and bypass the first pass metabolism thereby increase bioavailability. Nanoparticles (NPs) were prepared by nanoprecipitation method and films were prepared by a solvent casting method. Both the formulations were optimized employing central composite design. Nanoparticles were evaluated for particle size, zeta potential & entrapment efficiency, which were found to be 189.23 +/- 0.95 nm, -21.56 +/- 0.56 mV and 68.28 +/- 3.69%, respectively. Morphological characters were identified by scanning electron microscopy, transmission electron microscopy and atomic force microscopy. Solid state characteristic of the drug in the formulation was evaluated by X-ray diffraction. FDOFs were evaluated for their disintegration time, weight variation, thickness, tensile strength, and surface pH. Stability studies were performed at 25 degrees C/60% RH. The results manifested that the nanoparticles incorporated films of BH had good physicomechanical properties and optimum stability. They were found to be effective in exerting fast followed by sustained drug release action.