Accelerated dissolution method to facilitate in vitro evaluation of risperidone-containing microspheres

Abstract

Microspheres have gained much interest because of their simple and controllable manufacturing process, sustainedrelease profile, and drug stabilization. However, the in vitro dissolution test of sustained-release microspheres is time consuming and impedes the development and quality control of microsphere products. In this study, an accelerated dissolution method was established to develop and evaluate microspheres in a timely and cost-effective manner. The effects of dissolution media temperature, pH, and ethanol content on the dissolution behavior were investigated to optimize the accelerated dissolution method. Media containing 25% ethanol with pH 7.4 and 37 °C was suitable for the microspheres. The correlation between the real-time and accelerated dissolution tests was established successfully with an R2 = 0.9978, indicating potential to apply the accelerated dissolution method to the development and evaluation of microspheres.