A Better Batch
Today’s solid dose manufacturing reality still relies on skillful execution by operators
By Karen Langhauser, Chief Content Director, Pharmaceutical Manufacturing
"If I sent everyone in this class home with the same recipe for cookies, would all the cookies taste the same?” asked solid dose expert, Mike Tousey, during his recent Techceuticals “Manufacturing Process” training course. Knowing my own habit of carelessly mixing ingredients to the point where they actually take flight out of the bowl, I immediately knew the answer here was “no.” The reality is, even if everyone follows the same recipe, variables in environment, ingredients, equipment and skill still exist.
While cookie individuality isn’t always a bad thing, when it comes to solid dose manufacturing, the goal is consistent, reproducible results.
“Being on the process floor is like being a shortstop — you have to constantly adjust.”
– Mike Tousey
After decades spent perfecting the craft of tablet making, manufactures (and patients) continue to favor the familiar, accessible oral solid dose format. Despite the increasing number of injectable biologics, solid dose products are a proven pharmaceutical market mainstay. According to GoodRx data, the top 10 drugs based on monthly prescription volume in the U.S. are solid dosages. On the innovation front, 2017 saw the percentage of solid dose new molecular entities (NMEs) approved by the U.S. Federal Drug Association jump from 32 to 50 percent.
Success in solid dose manufacturing comes not only in creating and following the “recipe” for the right formulation, process and equipment selection, but in understanding how to make adjustments when variables threaten product quality. It is within these small details that properly trained and experienced operators can make a big difference.
Despite the frequently discussed concept of a fully automated, “hand’s-off” drug manufacturing process, there is still some art left to crafting high-quality tablets.
Love this Karen!