A Safety Evaluation Study in Mice Revealed that Albumin Dimer is Safe for Medical and Pharmaceutical Applications

• Hashimoto Mai

  Faculty of Pharmaceutical Sciences, Sojo University

• Chuang Victor Tuan Giam

  School of Pharmacy, Monash University Malaysia, Malaysia Campus, Malaysia

• Ishima Yu

  Department of Pharmacokinetics and Biopharmaceutics, Institute of Biomedical Sciences, Tokushima University

• Ikeda Mayumi

  Department of Pharmacokinetics and Biopharmaceutics, Institute of Biomedical Sciences, Tokushima University

• Maruyama Toru

  Graduate School of Pharmaceutical Sciences, Kumamoto University

• Yamasaki Keishi

  Faculty of Pharmaceutical Sciences, Sojo University DDS Research Institute, Sojo University

• Taguchi Kazuaki

  Faculty of Pharmacy, Keio University

• Otagiri Masaki

  Faculty of Pharmaceutical Sciences, Sojo University DDS Research Institute, Sojo University

抄録

Human serum albumin (HSA) dimer, where two molecules of HSA are genetically fused with a linker of 10 amino acid, has superior blood retention property, compared with HSA monomer. Moreover, HSA dimer derivative, s-nitrosated HSA dimer, functions as an enhanced permeability and retention effects enhancer. HSA dimer has gained considerable attention as drug delivery system carrier based on its prominent function. However, for the HSA dimer to be used clinically, the safety profile of the HSA dimer is required in order to exclude any potential toxicity or unwanted effects. Thus, the present study was undertaken to investigate the occurance of tissue damage and serologic changes due to repeated administration of HSA dimer (66.5 mg/kg) to mice every 3 d for 56 d, as part of a basic consideration on safety evaluation. The evaluation on survival, behavior and body weight indicate that HSA dimer has no effect on physical growth and physiological functions. Hematological tests suggest that HSA dimer has no direct influence on hemocytes, such as hemolysis and platelet aggregation. Moreover, plasma clinical chemistry and histological examinations indicate that the HSA dimer has no deleterious effect on liver and renal functions. The results obtained here indicate HSA dimer is safe and should be useful for medical and pharmaceutical applications.

収録刊行物

• BPB Reports

  BPB Reports 3 (2), 87-91, 2020

  公益社団法人 日本薬学会

キーワード

• albumin
• dimer
• toxicity tests
• safety evaluation
• medical and pharmaceutical application

詳細情報

• CRID: 1391975276383685632
• NII論文ID: 130007944885
• DOI: 10.1248/bpbreports.3.2_87
• ISSN: 2434432X
• Web Site: https://www.jstage.jst.go.jp/article/bpbreports/3/2/3_87/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2022123320
• 本文言語コード: en
• データソース種別:
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