OSD
Issues presented by extractables & leachables (E&L) have challenged formulation developers for some time. Everything from the primary and secondary packaging to the excipients used in the formulation must be investigated to avoid risk of tainted compounds affecting the drug product.
With the need to eliminate the presence of E&Ls being so important to both the therapeutic effectiveness of the product and patient safety, it’s key to ask: What causes the contamination risk in the formulation process, and how can it be avoided?
Various issues can be associated with the risk of E&L tainting. Some packaging and delivery devices can be more dangerous than others, inhalation devices and particular injectables being especially perilous. Advancements in the pharma landscape can also be a cause for concern, as new packaging formats and novel excipients create additional complexity.
Sustainable pharmaceutical companies have begun to embrace environmentally friendly packaging, which will also have to be studied and tested in order to determine how these unfamiliar materials will interact with drug products.
In a recent article with PMPS Magazine, Dr. Ramesh Jagadeesan, Head of Analytical Services at Recipharm, defines E&Ls and educates on the ideal extractables and leachables testing process to ensure that finished drug products are stable and safe.