A comprehensive evaluation of arginine and its derivatives as protein formulation stabilizers.

Acetyl arginine Arginine Arginine ethyl ester Protein aggregation Subvisible particle

Journal

International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127

Informations de publication

Date de publication:
25 Nov 2023
Historique:
received: 07 07 2023
revised: 14 10 2023
accepted: 21 10 2023
medline: 20 11 2023
pubmed: 24 10 2023
entrez: 23 10 2023
Statut: ppublish

Résumé

Arginine and its derivatives (such as arginine ethyl ester and acetyl arginine) have varying degrees of protein aggregation suppressor effect across different protein solutions. To understand this performance ambiguity, we evaluated the activity of arginine, acetyl arginine, and arginine ethyl ester for aggregation suppressor effect against human intravenous immunoglobulin G (IgG) solution at pH 4.8. Both arginine and its cationic derivative arginine ethyl ester in their hydrochloride salt forms significantly reduced the colloidal and conformational stability (reduced k

Identifiants

pubmed: 37871869
pii: S0378-5173(23)00966-3
doi: 10.1016/j.ijpharm.2023.123545
pii:
doi:

Substances chimiques

Protein Aggregates 0
Immunoglobulin G 0
Arginine 94ZLA3W45F

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

123545

Informations de copyright

Copyright © 2023 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Shavron Hada (S)

BK21 FOUR Team and Integrated Research Institute for Drug Development, College of Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic address: shavron.hada@dgu.ac.kr.

Urmila Burlakoti (U)

BK21 FOUR Team and Integrated Research Institute for Drug Development, College of Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic address: yourmila@dgu.ac.kr.

Ki Hyun Kim (KH)

BK21 FOUR Team and Integrated Research Institute for Drug Development, College of Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea. Electronic address: yourmila@dgu.ac.kr.

Ji Soo Han (JS)

Department of Pharmacy, College of Pharmacy, Mokpo National University, Muan 58554, Republic of Korea. Electronic address: hanjisu98@mokpo.ac.kr.

Min Ji Kim (MJ)

Department of Pharmacy, College of Pharmacy, Mokpo National University, Muan 58554, Republic of Korea. Electronic address: kh2shmjna@mokpo.ac.kr.

Nam Ah Kim (NA)

Department of Pharmacy, College of Pharmacy, Mokpo National University, Muan 58554, Republic of Korea; Department of Biomedicine, Health & Life Convergence Sciences, BK21 Four, Biomedical and Healthcare Research Institute, Mokpo National University, Muan 58554, Republic of Korea. Electronic address: namahk87@mnu.ac.kr.

Seong Hoon Jeong (SH)

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.

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Classifications MeSH