Stability by Design (SbD): Utilizing material science principles to predict physical and chemical stability of pharmaceutical solids

摘要

Ensuring, both, physical and chemical long-term stability of the drug product is one of the key requirements in successful drug formulation development. While significant knowledge exists on solution-state stability of pharmaceuticals, the predictive knowledge of solid-state physical and chemical stability in solid oral dosage forms is limited. Here we present two examples of our research towards achieving stability by design (SbD) for solid oral dosage forms through the use of in-silico methods to accelerate and streamline formulation development.