[learn_more caption=”Dr. Joseph Kushner, IV”] Dr. Kushner received a B.S. in Chemical Engineering from Arizona State University and completed a M.S. and Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology, conducting research in the field of ultrasound-mediated transdermal drug delivery. In 2006, he joined Pfizer as a research scientist in the Drug Product Design group, leading research efforts to better understand the role of excipient variability on drug product robustness and to improve understanding of the lubrication blending process. Dr. Kushner has authored over 20 publications and presentations in the fields of transdermal drug delivery, lubrication process understanding, and excipient variability in solid oral dosage forms. Outside of Pfizer, he has been involved with AIChE, AAPS and the IPEC Quality by Design committee. He is happily married to his wife, Jennifer, and has four children – Veronica, Felicity, Jack, and Anne.[/learn_more]

It is well-known that the addition of lubricants to pharmaceutical blends has an impact on the performance and manufacturability of drug products.  Therefore, from a Quality-by-Design perspective, it is necessary to understand the extent to which lubricants effect the quality attributes of drug products.  To facilitate this understanding, a process model for lubricant mixing has been developed to ensure that desired product performance characteristics identified in small-scale development studies can be maintained during the scale-up of a manufacturing process to commercial-scale levels.  Further, improved drug product robustness to lubrication effects can also be achieved through design of drug product formulations that are less sensitive to lubricant mixing.  These aspects of lubrication Quality-by-Design can be evaluated using material-sparing approaches, including compaction simulation.