Innovations In Linking Rational Design And Material-Sparing Strategies For Enabled Intermediates And Their Drug Products

Poorly soluble APIs present persistent challenges in enabled formulation development, where early risk identification can determine whether a program advances efficiently or stalls at the drug product stage. This executive summary presents a structured, material-sparing approach that connects physicochemical characterization and formulation mapping to lab-scale spray drying and a compact screening strategy designed to surface manufacturability, performance, and stability risks before committing to full tablet formulation.

Using erlotinib as a model compound, the approach is demonstrated across three distinct enabled forms: a spray-dried intermediate, a salt, and a co-crystal. The case study reveals meaningful differences in compressibility, disintegration behavior, and processing requirements across enabled form types, with specific findings informing downstream formulation decisions for each. Presented by formulation scientists Hannah Worrest, Bailey Coker, and Allison DuRoss, PhD, the paper offers a practical framework for teams navigating early feasibility work with limited API supply. Explore the full analysis to see how this approach translates property data into a rational drug product strategy.