Early-phase drug product (DP) manufacture from an active pharmaceutical ingredient (API) is often performed in the absence of fire and explosion data, as material for testing either does not exist or cannot be spared. This leads to onerous processing restrictions, as properties are assumed to be "worst case" or processes are run with an inadequate basis of safety, leading to accidents. Full testing for fire and explosion properties uses about 800 g of material. This paper discusses predictive methodologies used by GSK R&D based on chemistry knowledge and experiments using <1 g of material to identify "materials of concern" (e.g., low minimum ignition energy or adverse dust explosion properties) that require additional safety measures or accelerated testing. The methodology has been employed on over 20 compounds in GSK R&D.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.