Formulation and Quality – Chemical
2019 PharmSci 360
This prolog talk will give an overview of the symposium. In addition, case studies will be presented on accelerated release testing of microsphere products as well as intrauterine systems (IUS). Elevated temperature, pH adjustment and the use of organic solvents and/or surfactants will be discussed as methods to achieve accelerated release for these drug products. Correlation between “real-time” drug release and accelerated drug release will be presented for both microspheres and IUS drug products. Changes in microstructure have been shown to affect drug release from quantitatively and qualitatively equivalent microspheres, indicating the importance of developing methods to assess product microstructure. Examples will be presented including Naltrexone, Risperidone, Vivitrol and Lupron Depot PLGA microspheres.