PMID- 34237379
OWN - NLM
STAT- MEDLINE
DCOM- 20211231
LR  - 20211231
IS  - 1873-3441 (Electronic)
IS  - 0939-6411 (Linking)
VI  - 166
DP  - 2021 Sep
TI  - Off-label use of plastic syringes with silicone oil for intravenous infusion bags 
      of antibodies.
PG  - 205-215
LID - S0939-6411(21)00182-X [pii]
LID - 10.1016/j.ejpb.2021.07.001 [doi]
AB  - The formation of particulates in post-manufacture biopharmaceuticals continues to 
      be a major concern in medical treatment. This study was designed to evaluate the 
      content of micro-sized particles using flow imaging of antibodies in intravenous 
      infusion bags. Intravenous immunoglobulin (IVIG) and Avastin(R) were selected as 
      model drugs and plastic syringes with and without silicone oil (SO) were used to 
      transfer the drugs into the bags (0.9% saline or 5% dextrose). Antibodies exposed 
      to SO had significantly increased levels of microparticles in both diluents, 
      suggesting SO accelerates particle formation, especially at a higher antibody 
      concentration. Even before the drop stress, their count exceeded the USP 
      guideline. Dropping the bags in the presence of SO produced larger 
      microparticles. Meanwhile, air bubbles were retained longer in saline suggesting 
      more protein film formation on its air-water interface. Overall, both drugs were 
      conformationally stable and produced less particles in dextrose than in saline.
CI  - Copyright (c) 2021 Elsevier B.V. All rights reserved.
FAU - Kim, Nam Ah
AU  - Kim NA
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic 
      address: namah87@dongguk.edu.
FAU - Hada, Shavron
AU  - Hada S
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic 
      address: shavron.hada@gmail.com.
FAU - Kim, Dong Jun
AU  - Kim DJ
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic 
      address: 1993kdj@naver.com.
FAU - Choi, Du Hyung
AU  - Choi DH
AD  - Department of Pharmaceutical Engineering, Inje University, Gyeongnam 50834, 
      Republic of Korea. Electronic address: choidh@inje.ac.kr.
FAU - Jeong, Seong Hoon
AU  - Jeong SH
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic 
      address: shjeong@dongguk.edu.
LA  - eng
PT  - Journal Article
DEP - 20210706
PL  - Netherlands
TA  - Eur J Pharm Biopharm
JT  - European journal of pharmaceutics and biopharmaceutics : official journal of 
      Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
JID - 9109778
RN  - 0 (Excipients)
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Immunologic Factors)
RN  - 0 (Protein Aggregates)
RN  - 0 (Saline Solution)
RN  - 0 (Silicone Oils)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Biopharmaceutics/methods
MH  - Chemistry, Pharmaceutical/methods
MH  - Drug Compounding
MH  - Drug Stability
MH  - Excipients/pharmacology
MH  - Glucose/pharmacology
MH  - Immunoglobulins, Intravenous/administration & dosage/adverse effects
MH  - Immunologic Factors/administration & dosage/adverse effects
MH  - Infusions, Intravenous/adverse effects/methods
MH  - Off-Label Use
MH  - Particle Size
MH  - Protein Aggregates/*immunology
MH  - Saline Solution/pharmacology
MH  - Silicone Oils/*pharmacology
MH  - Syringes/*standards
OTO - NOTNLM
OT  - Avastin(R)
OT  - Flow imaging
OT  - IV infusion
OT  - IVIG
OT  - Silicone oil
OT  - Subvisible particle
EDAT- 2021/07/09 06:00
MHDA- 2022/01/01 06:00
CRDT- 2021/07/08 20:13
PHST- 2021/04/06 00:00 [received]
PHST- 2021/06/24 00:00 [revised]
PHST- 2021/07/02 00:00 [accepted]
PHST- 2021/07/09 06:00 [pubmed]
PHST- 2022/01/01 06:00 [medline]
PHST- 2021/07/08 20:13 [entrez]
AID - S0939-6411(21)00182-X [pii]
AID - 10.1016/j.ejpb.2021.07.001 [doi]
PST - ppublish
SO  - Eur J Pharm Biopharm. 2021 Sep;166:205-215. doi: 10.1016/j.ejpb.2021.07.001. Epub 
      2021 Jul 6.