STABLE, INJECTABLE NORADRENALINE SOLUTIONS FREE OF ANTIOXIDANTS

    公开(公告)号:US20230398070A1

    公开(公告)日:2023-12-14

    申请号:US18032188

    申请日:2021-09-29

    申请人: SINTETICA S.A.

    摘要: The invention concerns a process for producing a stable, injectable solution containing noradrenaline, comprising the following steps: (a) dissolving noradrenaline and optionally one or more excipients in deoxygenated or degassed water, in order to produce a solution containing noradrenaline; (b) distributing the noradrenaline solution in an inert gas current into a container; (c) sterilizing the solution containing, before step (b) and/or after step (d); (d) hermetically sealing the container; (e) wherein the oxygen concentration in the solution containing noradrenaline is less than 300 ppbw immediately after sealing the container; and (f) wherein the oxygen concentration in the headspace immediately after sealing the container is at most 1.0 percent v/v. It also concerns a drug product obtainable in particular by the above process, and the use of a gas atmosphere comprising an oxygen concentration of less than 1.0 percent v/v, as a headspace in a container comprising a solution containing noradrenaline. Finally, it concerns a process for reducing the number of subvisible particles in a solution containing noradrenaline.