Formulation and Quality – Chemical
2019 PharmSci 360
Solubility enhancing formulations are often metastable, undergoing phase transformations during storage or upon delivery. Comprehensive characterization encompasses understanding the thermodynamics, kinetics and extent of the phase transformation, as well as the the the properties of the materials resulting from the transformation. To successfully address the aforementioned goals, different analytical methods are needed. Herein, examples are provided of phase transformations occurring in amorphous solid dispersions, as well as from supersaturated solutions, and the application of orthogonal analytical approaches to understand the system behavior.