In-use stability of Rituximab and IVIG during intravenous infusion: Impact of peristaltic pump, IV bags, flow rate, and plastic syringes

[Display omitted] This study investigates the impact of intravenous (IV) infusion protocols on the stability of Intravenous Immunoglobulin G (IVIG) and Rituximab, with a particular focus on subvisible particle generation. Infusion set based on peristaltic movement (Medifusion DI-2000 pump) was compa...

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Bibliographic Details
Published in:International journal of pharmaceutics 2024-09, Vol.663, p.124577, Article 124577
Main Authors: Hada, Shavron, Shin, I Jeong, Park, Ha Eun, Kim, Ki Hyun, Kim, Kwang Joon, Jeong, Seong Hoon, Kim, Nam Ah
Format: Article
Language:English
Subjects:
Antibody infusion
Flow rate
Gravity infusion
Peristaltic pump
Subvisible particle
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Summary:[Display omitted] This study investigates the impact of intravenous (IV) infusion protocols on the stability of Intravenous Immunoglobulin G (IVIG) and Rituximab, with a particular focus on subvisible particle generation. Infusion set based on peristaltic movement (Medifusion DI-2000 pump) was compared to a gravity-based infusion system (Accu-Drip) at different flow rates. The impacts of different diluents (0.9 % saline and 5.0 % dextrose) and plastic syringes with or without silicone oil (SO) were also investigated. The results from the aforementioned particular case demonstrated that peristaltic pumps generated high levels of subvisible particles (prominently 
ISSN:0378-5173
1873-3476
1873-3476
DOI:10.1016/j.ijpharm.2024.124577