Pre-Formulation

Pre-formulation is essentially a forced degradation study prior to performing the full formulation development exercise. It relies on prior knowledge regarding routes of degradation and stability-indicating methods. Pre-formulation is required where little is known regarding the routes of degradation and/or stability-indicating methods. Using a range of forced degradation stresses, appropriate analytical methods can be evaluated for their stability-indicating ability. Such studies can also highlight the potential main routes of degradation.