Screening Methodologies to Expedite the Formulation Development of Amorphous Solid Dispersions

In recent years, there has been an increased interest in the use of amorphous solid dispersions (ASDs) to address the solubility constraints of the NCEs. The development of a new ASD is not straightforward and due to the high number of variables that may affect their stability and performance (e.g. different polymers, drug-polymer ratios, solvents, preparation methods, temperatures, etc) it became critical the development of new screening methodologies for narrowing the scope of formulations and to rapidly identify suitable systems for subsequent clinical evaluation. In this work, a model compound (Drug A) was used to demonstrate a new screening protocol, with special emphasis on the computational tools that make part of it and have recently been used to predict amorphous physical stability and performance.