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By Amitava Mitra

Amitava Mitra-finalAmorphous solid dispersion formulations have been widely used to enhance bioavailability of poorly soluble drugs, and several of these products (such as Belsomra, Kaletra, Kalydeco, Harvoni) have now been approved by regulatory agencies. However, there are several challenges associated with advancing amorphous drugs as they are inherently thermodynamically unstable. Despite significant advances in the understanding of amorphous solids and successful introduction of several commercial products, challenges still remain in predicting with confidence the preferred composition, manufacturing process, stability, and bioperformance of solid dispersions. Additionally, challenges exist in translational formulation science, engineering, and biopharmaceutics that provide multiscale linkages between in vitro, in silico, and in vivo quality and performance of amorphous formulations.

The 2016 Arden Conference will focus on sharing all aspects of current state of the art in fundamentals of amorphous solids, as well as advances in formulation, manufacturing, and biopharmaceutics of solid dispersions to enable wider utilization of these formulations. The April 18–20 conference in Baltimore will feature subject matter experts from academia, industry, and regulatory agencies giving up-to-date, in-depth presentations on the basic physics of the amorphous state; approaches for kinetic stabilization of amorphous pharmaceuticals with polymeric excipients to formulate solid dispersions; options for manufacturing of solid dispersions using different technologies; process modeling; in vivo behavior of supersaturated solutions; characterization of in vitro and in vivo performance of solid dispersions; and regulatory expectations for approval of solid dispersion products.

Along with opportunities for poster presentation, the conference will also provide a forum for pharmaceutical companies, excipient vendors, contract manufacturing organizations, academics, and regulatory agencies to discuss the state of the art in development and characterization of solid dispersions to support amorphous drug product development.

I hope you will join us in April to advance amorphous drug product development!

Amitava Mitra, Ph.D., is a principal scientist in biopharmaceutics at Merck. He holds a degree in pharmaceutical science from the University of Maryland Baltimore.