Issue link: https://www.e-digitaleditions.com/i/626800
A stability Using sorbents to ensure drug product integrity and mitigate risk Chris Gilmor and Joanne B. Miechowski Multisorb Technologies The integrity of drug products is paramount and protecting it requires mitigating the risks associated with product instability, poor quality systems, supply-chain disruptions, and poorly performing vendors. s pharmaceutical manufacturers seek to fill dwindling pipelines, they are developing new chemistries that are sometimes difficult to stabilize over the desired shelf life. Traditional moisture management alone is often insufficient, because many new drug products exhibit multiple, different degradation pathways. This article reviews how degrada- tion occurs and how sorbents work. It also provides advice about screening vendors and overcoming quality upsets. Understanding the top risks can help ensure product integrity and eliminate delays or disruptions in getting the product to market quickly. Time to market remains a key issue both for innovators launching a drug product and generic drug manufacturers seeking first-to-file advantage and the 6 months of market exclusivity that the Hatch- Waxman Act provides. Controlling degradation with sorbents From cracked tablets and capsules to reduced shelf lives and potency losses, drug product degradation can be disas- trous and might even prevent your product launch. An increase in moisture, for example, can cause chemical changes that reduce the potency of a product in several Tablets & Capsules January 2016 27