Nearly 90 % of new chemical entities (NCEs) in development have inadequate aqueous solubility and bioavailability properties, critical for their efficacy and commercialization. Over the past two decades, there has therefore been a substantial rise in the adoption of amorphous solid dispersion (ASD) and amorphous APIs as enabling technologies by pharmaceutical companies seeking to tackle these inadequacies (see Figure 1). To shed some light on why, when, and how to exploit the amorphous state of active pharmaceutical ingredients (APIs), we ask our formulation experts Oluwatomide Adeoye, Formulation Scientist, and Timothy Pas, Group Leader – Formulation Development and Production at Ardena, for their qualified opinion on the advantages, challenges, and strategies for utilizing ASD technology in early drug development through regulatory approval and commercialization.

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