Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
Revised Food Sanitation Act enforced in 2020 restricts food contact materials to those in the positive list supported by safety information. No similar list is available for pharmaceutical products at present. A pharmaceutical product often needs its own packaging suitable for the dosage and administration. It is difficult to apply a blanket restriction to various pharmaceutical products. Contact surface arias of pharmaceuticals and containers are usually much smaller than those of foods, it is reasonable to think that contaminants from containers are less in pharmaceuticals than food. However, there is no doubt that patients are exposed to the chemicals that unintendedly come from production instruments and containers of pharmaceutical products. A strongly toxic chemical in container closure systems is a big issue that exists with ordinary products. Lubbers used for injection formulations may contains a nitrosamine polymerization agent. Nitrocellulose in blister package may react with amines in printing ink to form nitrosamines. Lubbers and plastics include various additives to give batter plasticity and durability, details of which are not disclosed to users. Toxicologists have to estimate and assess leachables based on information of extractables that are detected under controlled extraction conditions. There are many issues e.g. we can find no safety information of a leachable. Here, I’d like to discuss background of requirement of safety assessment on extractables and leachables, and how toxicologists can approach to the issues.
