As regulatory pressure increases companies are saving time and money with effective extractables and leachables programmes
LGC, the international life sciences and measurement company, is successfully preventing pitfalls which can increase drug products time to market.
There is increasing regulatory pressure on pharmaceutical companies to investigate the potential interaction between a dosage form and the primary closure and transfer system employed. A thorough scientifically sound extractables and leachables (E&L) programme is, therefore, an essential regulatory requirement.
Designing and implementing a suitable E&L programme can save significant time and cost in development and ultimately help to ensure product safety of drug packaging and delivery systems.
LGC, which showcased its E&L services at CPhI 2016 in Barcelona, is helping customers to identify and quantify the compounds present in those components in direct contact with a drug product or patient and the likelihood of clinical exposure to these.
Mike Ludlow, Technical Study Manager, CMC Analytical Services at LGC, explains “LGC works with customers to provide extractables assessment and leachables analysis for a variety of drug formulations and delivery systems, including inhalers, injectables, ophthalmics, intra-venous products and blister packs. LGC has pre-developed survey methodology for the assessment of volatiles, semi-volatiles, non-volatiles and inorganic extractables. LGC discussed its expertise in this area at CPhI, including extraction, deformulation and characterisation of polymeric container devices and drug delivery systems.”
Together we are able to support our vision of science for a safer world
He added, “CPhI was such a worthwhile experience as we managed to meet with many new people and discussed the wide range of challenges involved in providing high quality E&L support for pharmaceutical product development. It was great to engage with industry peers and have constructive discussion, LGC is proud to work with clients and colleagues such as these. Together we are able to support our vision of science for a safer world.”