Small-Scale Prototyping with Scale in Mind: Building Drug Product Robustness Earlier

Small-scale formulation work is most valuable when it generates information that predicts clinical-scale performance rather than merely producing a promising prototype. This poster describes an intentional development workflow designed to minimize the gap between batches of only a few tablets and manufacturing at tens of thousands of tablets. The approach begins with target product profile and molecule-specific considerations, including physiological solubility, gelling tendency, excipient and intermediate compatibility, manufacturability, patient-population needs, and performance targets.

Formulations are then evaluated using equipment and parameters selected for translatability. Instrumented compaction simulation and integrated physical testing generate compaction, tensile-strength, solid-fraction, ejection-force, and related data that can be used to rank-order formulations and identify process risks before scale-up. The workflow also seeks to preserve clinically relevant milling and feeding mechanisms, screen size, gap, dwell time, and other scale-sensitive inputs so development materials better represent what will be encountered at manufacturing scale. Risk assessments capture unresolved performance, stability, manufacturability, and analytical issues and define next steps rather than allowing uncertainty to carry forward implicitly. The central message is that prototype development should be an exercise in building process understanding, not simply selecting a composition.

By deliberately linking small-scale experiments to the mechanics of commercial equipment and the needs of the final dosage form, development teams can make more confident formulation decisions, reduce scale-up variability, and enter clinical manufacturing with a more robust process foundation