Stability, dosage, and other challenges Developing an FDC formulation that offers these benefits and challenges can be difficult, however Because many active ingredients are incompatible-meaning they are less stable in the presence of each other-selecting excipients and processes that reduce the degradation rate of the active ingredients and afford the optimal composition and process parameters increases in difficulty as the number of active ingredients increases, Gren notes [ ]the main challenge to fixed-dose combination development usually involves product formulation and manufacturing strategy to address stability, dose differential, and analytical method development issues, according to Kane [ ]Kane observes that the packaging of a fixed-dose combination product may need to be re-considered based on the criticality of the multiple actives and their stability profiles in combination
Characterizing APIs is Essential for Combo Drug Formulations