ABSTRACT
The container closure system is indispensable to metered-dose inhaler (MDI). In the shelf life of MDI, various ingredients of the container closure system may become potential leachables and migrate into the preparation. Due to their unknown constructs and latent ambiguous toxicities, leachables may significantly affect drugs’ effectiveness and safety. Consequently, it is necessary to carry on leachable studies to ensure the good compatibility of MDI closure system. This paper mainly focuses on the fundamental components of MDI container closure system, analyzes leachable sources and safety information and reviews the related contents about leachable studies in domestic and foreign pharmacopoeia.
ABSTRACT
The container closure system is indispensable to metered-dose inhaler(MDI). In the shelf life of MDI,various in?gredients of the container closure system may become potential leachables and migrate into the preparation. Due to their unknown con?structs and latent ambiguous toxicities,leachables may significantly affect drugs′effectiveness and safety. Consequently,it is neces?sary to carry on leachable studies to ensure the good compatibility of MDI closure system. This paper mainly focuses on the fundamen?tal components of MDI container closure system,analyzes leachable sources and safety information and reviews the related contents about leachable studies in domestic and foreign pharmacopoeia.