METHOD AND PACKAGE FOR REDUCING THE DEGRADATION OF A DRUG AND/OR EXCIPIENT, E.G. POLYSORBATE STABILIZER, IN A PHARMACEUTICAL PRODUCT

• Main Authors: ABRAMS, Robert S, WEIKART, Christopher
• Format: Patent
• Language: English; French
• Published: 03.02.2022
• Subjects: AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F,C08G; CHEMICAL COMPOSITION OF GLASSES, GLAZES, OR VITREOUSENAMELS; CHEMICAL SURFACE TREATMENT; CHEMISTRY; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATIONOR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY IONIMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; COATING MATERIAL WITH METALLIC MATERIAL; COATING METALLIC MATERIAL; COMPOSITIONS BASED THEREON; DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROMTHE BODY; DIFFUSION TREATMENT OF METALLIC MATERIAL; GENERAL PROCESSES OF COMPOUNDING; GLASS; HUMAN NECESSITIES; HYGIENE; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION INGENERAL; JOINING GLASS TO GLASS OR OTHER MATERIALS; MEDICAL OR VETERINARY SCIENCE; METALLURGY; MINERAL OR SLAG WOOL; ORGANIC MACROMOLECULAR COMPOUNDS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS,MINERALS OR SLAGS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THESURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; THEIR PREPARATION OR CHEMICAL WORKING-UP; WORKING-UP

The present disclosure is directed to a vessel having a lumen defined at least in part by a wall, the wall having an interior surface facing the lumen, and the interior surface comprising a coating. The coating is configured to prevent the leaching of metal ions from the vessel wall into a fluid contained within the lumen and stored in contact with the coating. The vessels are used to store an aqueous drug product, typically an aqueous drug product containing an active agent and one or more exceipients, such as a polysorbate stabilizer. The coated vessels are effective to reduce degradation of the active agent and/or one or more excipients, e.g. a polysorbate stabilizer. La présente invention concerne une enceinte ayant une lumière définie au moins en partie par une paroi, la paroi ayant une surface intérieure faisant face à la lumière, et la surface intérieure comprenant un revêtement. Le revêtement est configuré pour empêcher la lixiviation d'ions métalliques à partir de la paroi d'enceinte dans un fluide contenu à l'intérieur de la lumière et stocké en contact avec le revêtement. Les récipients sont utilisés pour stocker un produit médicamenteux aqueux, typiquement un produit médicamenteux aqueux contenant un agent actif et un ou plusieurs excipients, tels qu'un stabilisant polysorbate. Les enceintes revêtues sont efficaces pour réduire la dégradation de l'agent actif et/ou d'un ou de plusieurs excipients, par exemple un stabilisant polysorbate.