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    视频

    Comparison of botulinum neurotoxin type A formulations in Asia

     

    Authors Frevert J, Ahn KY, Park MY, Sunga O

    Received 23 December 2017

    Accepted for publication 5 April 2018

    Published 5 July 2018 Volume 2018:11 Pages 327—331

    DOI http://doi.org/10.2147/CCID.S160723

    Checked for plagiarism Yes

    Review by Single-blind

    Peer reviewers approved by Dr Andrew Yee

    Peer reviewer comments 4

    Editor who approved publication: Dr Jeffrey Weinberg

    Introduction: All protein-based therapeutics, such as botulinum neurotoxin type A (BoNT/A), are potentially immunogenic and can lead to anaphylaxis, autoimmunity, or diminished or complete absence of therapeutic efficacy, especially if administered repeatedly. Therefore, the protein quantity in BoNT/A products is an important consideration when selecting products for treatment. However, essential formulation data are not always publicly accessible. 
    Materials and methods: The neurotoxin protein content of products newly introduced in Asia, such as (listed alphabetically) Botulax
    ®, Meditoxin®, Nabota®, and Relatox®, was measured by sandwich enzyme-linked immunosorbent assay with antisera directed against BoNT/A compared to Xeomin®.
    Results: Compared to Xeomin with no inactive neurotoxin, although Botulax and Nabota contained 844 and 754 pg of neurotoxin protein, respectively, the percentage of inactive neurotoxin was calculated to be 103 and 81, respectively, while the potency per pg of neurotoxin was 0.118 and 0.133 U, respectively. Meditoxin and Relatox had 575 and 578 pg of neurotoxins, respectively, marginally higher than that of Xeomin, while the percentage of inactive neurotoxins was 38 and 33, respectively, and the potency per pg of neurotoxin was 0.174 and 0.173 U, respectively. However, Xeomin, which has 416 pg/vial of purified neurotoxin and 0.240 U of efficacy per pg of neurotoxin, has the lowest neurotoxin protein content and consequently the highest specific potency compared to the four Asian BoNT/A preparations in this study.
    Conclusion: Although Botulax and Nabota had more neurotoxin than Xeomin in an equivalent volume, they contained greater amounts of inactive neurotoxin. In addition, although Meditoxin and Relatox had slightly more neurotoxin than Xeomin, both contained greater amounts of inactive neurotoxin.
    Keywords: botulinum neurotoxin type A, purity, potency, immunogenicity, Asia

     


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