Formulation and Quality – Chemical
2019 PharmSci 360
This presentation will describe the development of an accelerated analytical method ( 2 weeks long) to predict the long term release (4-6 months) of a peptide from a polymeric formulation. The development included the investigation of pH, surfactant, buffer type, co-solvents, temperature, stirring speed...etc. Additionally, the presentation will illustrate the development of an accelerated method (1 month long) to predict the long term ( >= 10 months) polymer degradation. The two methods were successfully used to enable and accelerate formulation development.