“…26,27 Polymorphism is estimated to occur in up to 80% of molecules that display pharmaceutical applications, 27,28 affecting properties of the solid state (stability, solubility, dissolution rate, and bioavailability), and therefore, the quality and efficacy of the final drug product. 24,26,27,[29][30][31][32] The unsubstantiated notion that undesired polymorphic phase transformations might occur during HME limits the application of this technique to produce crystalline solid dispersions for a narrow set of APIs that are both thermally stable and monomorphic (∼20%). 27,28 However, taking into consideration other industrial processes, this sentiment might be founded on insufficient knowledge of the thermodynamic and kinetic boundaries, in other words, the design space of a particular HME process.…”