Up to 70% of compounds in modern Discovery portfolios are insoluble in water.  More than ever before, many of these compounds are being advanced into the clinic.  As such, the pharmaceutical industry is increasingly embracing new technologies that can enable high absorption of these compounds.  Amorphous solid dispersions are being utilized extensively and have demonstrated recent commercial success.  Preferred processes are spray drying and twin-screw melt extrusion, which are well established.  However, the need for rigorous science-based methods for rapid and early selection of amorphous solid dispersion formulations remains, especially for application in Discovery.  Such methods would ideally address 1) selection of excipient and API loading, 2) assessment of in vivo relevant performance, 3) solid-state characterization, and 4) solid dosage form considerations.  This presentation will provide an overview of these critical scientific issues that must be addressed in order to develop commercially viable, robust, and stable formulations.

Application of scalable amorphous drug delivery systems in discovery and clinical development

244th National Meeting (2012)

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