Drug-delivery devices release a drug product over time into the human body. Depending on whether the product is intended to be submitted as a medical device or as a pharmaceutical drug product, the requirements for extractable and leachable (E&L) testing may differ. E&L testing for medical devices is typically defined as chemical characterization of medical device materials per ISO 10993-18.
An E&L study for pharmaceutical drug products typically follows USP <1663> and <1664> for extractables and leachables associated with pharmaceutical packaging/delivery systems.
Katie Grayson, a general manager at EKG labs, will present an overview of E&L studies, comparing and contrasting E&L requirements between pharmaceutical products and medical devices. Key elements regarding E&L study design of drug-delivery products will be discussed. Case studies on the E&L testing of drug-delivery products will be presented, including implantable infusion pumps and prefilled syringes.