digiM Webinar: Optimizing Enabled Formulations for Clinical Scale Up

Optimizing Enabled Formulations for Clinical Scale Up

Microstructure Role in Performance and Processability

The critical attributes of amorphous solid dispersions and granular intermediates go far beyond particle size. Internal porosity, surface area, particle wall thickness, and ingredient contact area can have significant impact on manufacturability and dissolution. These CQAs impact the corresponding structures in the final dose form, and thus driving release mechanisms for dissolution. To assure success in clinical scale up and dissolution robustness, setting benchmarks on particle attributes and optimizing them accordingly can be essential in product development. In this webinar, the use of advanced imaging techniques and AI analysis to quantify critical quality attributes of amorphous solid dispersion particles, granules, and final doses will be covered. Case studies from industry will explore how advanced microstructure characterization can guide manufacturing science, troubleshoot scale up challenges, and determine the most ideal dispersion manufacturing method. Implications for formulation selection, process development, product quality, and regulatory submissions are reviewed.

Learning Objectives

Introduction of morphology considerations for amorphous solid dispersions
Relationship of particle attributes to processing and dissolution
Characterization role in development decisions, assurance for derisking, and product quality assessments