Our client, a leading pharmaceutical company, sought a comprehensive assessment of the Extractables and Leachables (E&L) profile associated with their Fentanyl Transdermal System packaging. With a commitment to ensuring product safety and compliance, they aimed to understand the potential impact of packaging components on the drug product.
The Fentanyl Transdermal System comprises multiple packaging components, including Backing Film, Release Liner, Lidstock, Pouch Stock, and Blister Tray. The challenge lay in identifying and quantifying extractable impurities that could potentially migrate into the drug product and assessing the impact on product quality and safety.
For a two-part solution, first we designed a comprehensive protocol involving controlled extraction studies using pH 4.5 Water, pH 7.0 Water, and IPA at 50°C for 72 hours. Impurities were analyzed using HS-GC/MS, GC/MS & LC/MS, with a reporting limit set at half of the determined Acceptable Exposure Threshold (AET).
To meet the specific needs of a transdermal system, we also conducted a rather unique leachable study in parallel, using artificial sweat at 40°C for 72 hours on fresh and aged samples with the current and proposed pouch stock.
We prioritize safety and compliance for the Fentanyl Transdermal System by thoroughly addressing impurities above 80 μg/mL in traditional closures and multi-component patches. Our approach involves rigorous identification techniques and robust methods, underscoring our commitment to delivering high-quality solutions.