Ophthalmic Drug Products – Addressing the E&L Challenge

Ophthalmic drug products (ODPs) present a special challenge for the measurement of extractables and leachables (E&L) due to the presence of multiple leachables sources. ODPs typically are packaged in labelled, semipermeable polymer (e.g., low density polyethylene) containers (i.e., primary container) and stored in cardboard containers (i.e., secondary container) along with instructions for use. The polymer, label, cardboard and paper are all possible sources of leachables.

Even though The Product Quality Research Institute (PQRI) groups parenteral and ophthalmic drugs together, an ODP extractables study requires a different approach. The first step of this approach is an extractables study of the primary package itself, which typically includes the container, dropper tip and cap. The next step is what distinguishes ODPs – a simulation study is needed. Direct evaluation of the extractables of secondary container components is impractical and would not constitute a realistic examination. The simulation study comprises examination of extractables in the primary container while it is stored in the secondary container. This enables evaluation for any component that might move through the semipermeable primary package into the ODP. This is an excellent example of how all extractables studies require a custom approach.

E&L is a thrust area for West Analytical Services, which maintains the staff, expertise, and facility to conduct such studies. Committed to safe and efficient delivery of all drug products, West offers services even for non-West products. For more on how West can help, please visit our extractables and leachables testing page or contact an Account Manager or Technical Customer Service representative.