Journal Article

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

Teissy Osaki, Midori H. Osaki, Tammy H. Osaki, Ana Estela Sant'Anna, Maria Cecilia Z. Yu and Ana Luisa Hofling-Lima

in Aesthetic Surgery Journal

Published on behalf of The American Society for Aesthetic Plastic Surgery

Volume 35, issue 2, pages 189-193
Published in print February 2015 | ISSN: 1090-820X
Published online February 2015 | e-ISSN: 1527-330X | DOI: https://dx.doi.org/10.1093/asj/sju072
Absence of Bacterial or Fungal Growth in Vials of Reconstituted Botulinum Toxin Type A After Storage

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  • Dermatology
  • Surgery
  • Plastic and Reconstructive Surgery

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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.

Journal Article.  2432 words. 

Subjects: Dermatology ; Surgery ; Plastic and Reconstructive Surgery

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