Extractable and Leachable substances testing together with toxicological assessment and risk analysis is extremely important to protect patient health, assure product quality and arrange regulatory documentation. The interaction between the different types of packaging and the drug may affect the composition of the latter, thus adversely impacting its ability to produce the expected clinical outcome or its safeness.
- The controlled extraction studies can be enable to define impurities, which could migrate from polymeric materials and thus anticipate the leachable presence in drug product.
- The toxicological evaluation and risk analysis of the results obtained in extraction studies allow us to check the suitability of packaging materials or single-use systems for their use in the manufacturing of pharmaceutical products.
- Relationship betweeen extractables and leachables
- Design of a study
- Analytical Evaluation Threshold (AET) concept
- Extraction solvents, techniques and conditions
- Analytical techniques for scouting and characterization
- Regulation and requirements for E&L
- Toxicological evaluation and risk analysis of test results
Victoria López Prado is senior toxicology technician at Azierta Madrid
She holds a bachelor's degree in Pharmacy and a Ph.D. in Sustainable Chemistry obtained in Polytechnic University of Valencia. She later obtained an M.Sc. in Toxicology at the Official School of Chemistry of Sevilla.
She is specialized in regulatory toxicology and she works for clients from pharmaceutical and chemical industry. She is involved in preparing toxicity and hazard reviews and toxicological risk assessments of extractable, leachable and organic impurities appearing in drug products. She is also skilled at running QSAR predictions of toxicology. Her recent publications are focused on the safety evaluation of polymeric materials involved in drug products packaging and manufacturing.
Enrico Nieddu is the Director of the Science Center in Mérieux NutriSciences Laboratories, Italy
He studied Chemistry at Venice University, where he conducted researches on the pollutants of the Adriatic Sea. Since 1999 he has been working in the Packaging Division of Chelab Laboratories, holding different scientific and management positions. He has been involved in various scientific activities concerning Food Packaging Safety and, due to his experience on Compostable plastics, he is a member of the EU Bioplastic Advisory Committee. In 2012 Chelab became part of Mérieux NutriSciences international group and he took the lead of several food safety projects, based on non-targeted analyses. From 2018 he is in the management team of AIBO (Italian Food Contact Expert association).