RESUMEN
@#Taking plastic packaging materials as an example, this paper mainly summarizes the general principles of pharmacopoeias and guiding principles of relevant government departments related to the compatibility studies of drugs and packaging materials at home and abroad, with much reference to relevant monographs and literature. The purpose and specific methods of extraction and interaction studies are summarized and discussed. The existing problems and solutions in compatibility research are also proposed in this review to provide some refe-rence for researchers in relevant fields.
RESUMEN
@#Taking plastic packaging materials as an example, this paper mainly summarizes the general principles of pharmacopoeias and guiding principles of relevant government departments related to the compatibility studies of drugs and packaging materials at home and abroad, with much reference to relevant monographs and literature. The purpose and specific methods of extraction and interaction studies are summarized and discussed. The existing problems and solutions in compatibility research are also proposed in this review to provide some refe-rence for researchers in relevant fields.
RESUMEN
@#Pre-filled syringes are becoming increasingly popular for packaging and delivering system of pharmaceutical products. However, their compatibility with biotherapeutics needs to be carefully assessed. This review highlights and makes critically review on the extractables and leachables, the safety evaluation and analytical methods related to the compatibility study.
RESUMEN
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.
RESUMEN
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.