Absence of Bacterial or Fungal Growth in Vials of Reconstituted Botulinum Toxin Type A After Storage

Absence of Bacterial or Fungal Growth in Vials of Reconstituted Botulinum Toxin Type A After Storage

Author Osaki, Teissy Autor UNIFESP Google Scholar
Osaki, Midori H. Autor UNIFESP Google Scholar
Osaki, Tammy H. Autor UNIFESP Google Scholar
Sant'Anna, Ana Estela Autor UNIFESP Google Scholar
Yu, Maria Cecilia Z. Autor UNIFESP Google Scholar
Hofling-Lima, Ana Luisa Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Abstract Background: Botulinum toxin type A (BTX-A; Botox) is supplied as individual freeze-dried preparations that should be administered within 24 hours after reconstitution. To avoid wasting this expensive drug, some physicians have resorted to storing vials of reconstituted BTX-A beyond the recommended duration. However, there is insufficient evidence to indicate that the sterility of previously reconstituted BTX-A is maintained during storage.Objectives: the authors sought to determine whether bacterial and/or fungal proliferation occurred in vials of reconstituted BTX-A and subsequent storage of the remaining solution under refrigeration for 4 weeks.Methods: A portion of the contents of 88 consecutive 100-U vials of BTX-A was administered aseptically to 108 patients for essential blepharospasm, hemifacial spasm, or facial rejuvenation. the vials were then stored for 4 weeks in a refrigerator, after which the contents were transferred to various media (blood agar, chocolate agar, Sabouraud agar, brain-heart infusion medium, and thioglycolate broth) and assessed for bacterial and/or fungal growth by standard methods.Results: None of the BTX-A vials contained detectable bacterial or fungal contamination after 4 weeks of storage.Conclusions: Storing vials of reconstituted BTX-A for 4 weeks after administration to patients was not associated with detectable growth of bacteria or fungi.
Language English
Date 2015-02-01
Published in Aesthetic Surgery Journal. Cary: Oxford Univ Press Inc, v. 35, n. 2, p. 189-193, 2015.
ISSN 1090-820X (Sherpa/Romeo, impact factor)
Publisher Oxford Univ Press Inc
Extent 189-193
Origin http://dx.doi.org/10.1093/asj/sju072
Access rights Closed access
Type Article
Web of Science ID WOS:000351914800019
URI http://repositorio.unifesp.br/handle/11600/38719

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