Antonios Zavaliangos, A.W. Grosvenor Professor of materials science and engineering, has received a three-year grant from the Enabling Technology Consortium for his project “Accurate and repeatable measurements of adhered material growth on pharmaceutical tableting tools.”
Some pharmaceutical formulations of tablets are prone to sticking, a serious manufacturing problem in which tablet materials adhere to the punches causing defects in the tablets. Unfortunately, it’s a problem that is not usually identified until after thousands of tablets have already been produced and identification requires stopping production until the problem is addressed. As a result, many times this problem goes undetected in early R&D. There is a critical time in production at which the composition is set, and FDA approval is requested. Before this point, the engineers can modify the formulation or the processing of the powders. “If you’ve figured out that there’s a problem after that,” says Zavaliangos, “everything becomes expensive. Clinical studies may have to be repeated with significant cost and delay till the drug reaches the market.” And if the problem isn’t identified until full manufacturing is underway then “every day that you have manufacturing down, it could be millions of dollars in cost,” Zavaliangos notes.
Zavaliangos’ project seeks to address these issues by enabling an early detection of the problem using minimal amounts of material. Instead of needing thousands of tablets for detection, his group will test a sensor they have developed and a testing method (Single Tablet Multi Compaction technique) that is capable of assessing sticking with few grams of material.
“Even if it only works in half of the cases, if we understand why it works, and when it might fail, that’s much better than what we have now,” says Zavaliangos. “That is really the advantage of this project.”