Characterization of Solid-State Phase Morphology in Amorphous Solid Dispersions

A common property among drug candidates is poor water solubility, which limits their uptake in the body. In response, an amorphous solid dispersion (ASD) is a pharmaceutical formulation that uses a polymer matrix to kinetically trap amorphous phases of the active pharmaceutical ingredient (API) to improve its solubility and efficacy. They can be formulated as pills or implants, and their dissolution profile is directly related to the morphology of the API-rich phase which is sensitive to both composition and processing conditions of the blends. In this work, we will use SESANS to characterize the degree of phase separation in these materials, understand the mechanism by which the polymer traps amorphous forms of the API, and answer the question: how does ASD phase morphology change as a function of active phase concentration and choice of polymer matrix?