Edward Yost, Genentech

Small-scale and material-sparing techniques for predictive assessment of the risk of physical defects in tablets – such as breakage during storage, shipping, or coating – are usually missing or inadequate in literature and have primarily remained empirical.  Observations of tablet lamination or fracturing during friability or hardness testing typically assess the potential for the risk of tablet breakage.  These are subjective “yes or no” observations.  They do not quantitatively delineate the role of formulation and process variables in causing such defects, which is essential for quality-by-design drug product development and generally not amenable for application as a response parameter in design-of-experiment studies.

Increasing tablet product quality knowledge quantitatively using laser ablation, ultrasonic analysis, and x-ray microcomputed tomography (XμCT) expand our analysis of tablet defects.  Furthermore, XμCT with artificial intelligence-based image analysis provides an opportunity to quantify the internal structure of tablets and move from an empirical to mechanistic understanding of tablet defects.

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Edward Yost

Ed is a Sr. Scientific Researcher in the small molecule pharmaceutics group at Genentech. He has 18 years of small molecule formulation development experience – injectable, meter dose inhaler, dry powder inhaler, and immediate release tablet dosage forms – from pre-clinical to late-stage development. During the past 11 years at Genentech, he has developed dry powder inhaler and tablet formulations while implementing mechanical property and process simulation assessment strategies. Ed is the current chair of the AAPS Bay Area Discussion Group, and his research interests include process simulation for material-sparing tablet development and particle dispersion for inhalation delivery.