Simultaneous water sorption and crystallization in ASDs 2: modeling long-term stabilities

B Grönniger, E Fritschka, K Kimpe… - Molecular …, 2024 - ACS Publications
The physical stability of amorphous solid dispersions (ASDs) is a major topic in the
formulation research of oral dosage forms. To minimize the effort of investigating the long …

Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient

RK Orr, T Rawalpally, LS Gorka, LR Bonaga… - The AAPS Journal, 2024 - Springer
A co-processed active pharmaceutical ingredient (CP API) is the combination of an active
pharmaceutical ingredient (API) with non-active component (s). This technology has been …