TY - JOUR

T1 - Comparative study between a gravity-based and peristaltic pump for intravenous infusion with respect to the generation of proteinaceous microparticles

AU - Hada, Shavron

AU - Ji, Sunkyong

AU - Lee, Ye Na

AU - Kim, Ki Hyun

AU - Maharjan, Ravi

AU - Kim, Nam Ah

AU - Rantanen, Jukka

AU - Jeong, Seong Hoon

N1 - Funding Information: This study was supported by the National Research Foundation of Korea grant funded by the Korean government (NRF-2018R1A5A2023127 and NRF-2019R1A2C1083911). Special thanks to Hanvit MD for designing the accurate gravity-based infusion system with technical support from the Korea Aerospace Research Institute. Publisher Copyright: © 2023 Elsevier B.V.

PY - 2023

Y1 - 2023

N2 - Subvisible particles generated during the preparation or administration of biopharmaceuticals might increase the risk of immunogenicity, inflammation, or organ dysfunction. To investigate the impact of an infusion system on the level of subvisible particles, we compared two types of infusion sets based on peristaltic movement (Medifusion DI-2000 pump) and a gravity-based infusion system (Accu-Drip) using intravenous immunoglobulin (IVIG) as a model drug. The peristaltic pump was found to be more susceptible to particle generation compared to the gravity infusion set owing to the stress generated due to constant peristaltic motion. Moreover, the 5-µm in-line filter integrated into the tubing of the gravity-based infusion set further contributed to the reduction of particles mostly in the range ≥ 10 µm. Furthermore, the filter was also able to maintain the particle level even after the pre-exposure of samples to silicone oil-lubricated syringes, drop shock, or agitation. Overall, this study suggests the need for the selection of an appropriate infusion set equipped with an in-line filter based on the sensitivity of the product.

AB - Subvisible particles generated during the preparation or administration of biopharmaceuticals might increase the risk of immunogenicity, inflammation, or organ dysfunction. To investigate the impact of an infusion system on the level of subvisible particles, we compared two types of infusion sets based on peristaltic movement (Medifusion DI-2000 pump) and a gravity-based infusion system (Accu-Drip) using intravenous immunoglobulin (IVIG) as a model drug. The peristaltic pump was found to be more susceptible to particle generation compared to the gravity infusion set owing to the stress generated due to constant peristaltic motion. Moreover, the 5-µm in-line filter integrated into the tubing of the gravity-based infusion set further contributed to the reduction of particles mostly in the range ≥ 10 µm. Furthermore, the filter was also able to maintain the particle level even after the pre-exposure of samples to silicone oil-lubricated syringes, drop shock, or agitation. Overall, this study suggests the need for the selection of an appropriate infusion set equipped with an in-line filter based on the sensitivity of the product.

KW - Flow imaging

KW - Gravity infusion

KW - Infusion pump

KW - Peristaltic pump

KW - Protein aggregation

KW - Subvisible particle

U2 - 10.1016/j.ijpharm.2023.123091

DO - 10.1016/j.ijpharm.2023.123091

M3 - Journal article

C2 - 37268032

AN - SCOPUS:85161560776

VL - 642

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

SN - 0378-5173

M1 - 123091

ER -