Method for reducing an amount of subvisible particles in pharmaceutical composition

• Main Authors: BENOIT FREMON, JEAN-BERNARD HAMEL, TZVETELINA CHEVOLLEAU, SEBASTIEN JOUFFRAY
• Format: Patent
• Language: Chinese; English
• Published: 19.01.2018
• Subjects: APPLYING LIQUIDS OR OTHER FLUENT MATERIALS TO SURFACES, IN GENERAL; 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; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PERFORMING OPERATIONS; PROCESSES FOR APPLYING LIQUIDS OR OTHER FLUENT MATERIALS TOSURFACES, IN GENERAL; SPRAYING OR ATOMISING IN GENERAL; TRANSPORTING

The invention relates to a method for reducing an amount of subvisible particles in a pharmaceutical composition contained in a medical injection device comprising a container (1) including a barrel (10) lubricated with a lubricant coating (2) in contact with the pharmaceutical composition, and a stopper (14) in sliding engagement within the barrel (10), the container comprising a region (130, 121, 123) extending distally from the distal end (100) of the barrel which is not accessible to the stopper. During formation of the lubricant coating (2) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into the region (130, 121, 123) extending distally from the distal end (100) of the barrel. 本发明涉及减少药物组合物中亚可见颗粒的量的方法，药物组合物被容纳在医用注射装置中，医用注射装置包括：容器(1)，容器包括利用润滑剂涂层(2)来润滑的筒体(10)，润滑剂涂层与药物组合物接触；和塞子(14)，塞子在筒体(10)内滑动地接合，容器包括从筒体的远端(100)向远侧延伸的区域(130，121，123)，所述区域不能被塞子进入。在筒体的内壁上形成润滑剂涂层(2)期间，该方法包括限制润滑剂沉积到从筒体的远端(100)向远侧延伸的所述区域(130，121，123)中。