Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins

Krayukhina, Elena; Tsumoto, Kouhei; Uchiyama, Susumu et al.

Journal of Pharmaceutical Sciences, 2015, 104(2), 527-535

アクセス数:591件（2025-09-11 12:56 集計）

固定URL: https://hdl.handle.net/11094/79032

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論文情報

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タイトル
Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins
著者
著者名
Krayukhina, Elena
NRID
1000090271866 1000090271866
著者名
Tsumoto, Kouhei
NRID
1000090335381 1000090335381
ORCID
0000-0002-5181-179X 0000-0002-5181-179X
researchmap permalink
read0090387 read0090387
Scopus Author ID
35429790100 35429790100
著者名
Uchiyama, Susumu
NRID
1000000311770 1000000311770
researchmap permalink
read0068600 read0068600
著者名
Fukui, Kiichi
キーワード等
protein aggregation
prefilled syringe
physical stability
silicone oil
biopharmaceuticals characterization
subvisible particles
HPLC (high-performance/pressure liquid chromatography)
analytical ultracentrifugation
UV/Vis spectroscopy
Imaging methods
内容
Elena Krayukhina, Kouhei Tsumoto, Susumu Uchiyama, Kiichi Fukui. Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins. Journal of Pharmaceutical Sciences, Volume 104, Issue 2, 2015, Pages 527-535. ttps://doi.org/10.1002/jps.24184.
抄録
Currently, polymer-based prefillable syringes are being promoted to the pharmaceutical market because they provide an increased break resistance relative to traditionally used glass syringes. Despite this significant advantage, the possibility that barrel material can affect the oligomeric state of the protein drug exists. The present study was designed to compare the effect of different syringe materials and silicone oil lubrication on the protein aggregation. The stability of a recombinant fusion protein, abatacept (Orencia), and a fully human recombinant immunoglobulin G1, adalimumab (Humira), was assessed in silicone oil-free (SOF) and silicone oil-lubricated 1-mL glass syringes and polymer-based syringes in accelerated stress study. Samples were subjected to agitation stress, and soluble aggregate levels were evaluated by size-exclusion chromatography and verified with analytical ultracentrifugation. In accordance with current regulatory expectations, the amounts of subvisible particles resulting from agitation stress were estimated using resonant mass measurement and dynamic flow-imaging analyses. The amount of aggregated protein and particle counts were similar between unlubricated polymer-based and glass syringes. The most significant protein loss was observed for lubricated glass syringes. These results suggest that newly developed SOF polymer-based syringes are capable of providing biopharmaceuticals with enhanced physical stability upon shipping and handling.
出版者
Elsevier
収録物名
Journal of Pharmaceutical Sciences
巻(号)
104(2)
ページ
527-535
刊行年月
2015-02-01
言語
英語
ハンドルURL
https://hdl.handle.net/11094/79032
PISSN
00223549
eISSN
15206017
NCID
AA00704450
関連情報 (isIdenticalTo)
DOI (出版社版)
https://doi.org/10.1002/jps.24184
PMID
25256796
アクセス権
open access
権利情報
© 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association. Published by Elsevier Inc. This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
出版タイプ
Version of Record
カテゴリ
学術雑誌論文 Journal Article