Korean J Dermatol.  2000 Oct;38(10):1325-1332.

Effect of Storage Temperature and Durationon Potency of Botulinum Toxin

Affiliations
  • 1Department of Dermatology, College of Medicine, Yeungnam University, Taegu, Korea.

Abstract

BACKGROUND: FDA recommend that botulinum toxin should be used within 4 hours after reconstruction. Because botulinum toxin is very expensive and also only small amounts of botulinum toxin are needed for one lesion, it should be used for several patients simultaneously to reduce cost. The reports on the decrease of potency according to storage temperature and duration were contradictory among the investigators. OBJECTIVE: The purpose of this study is to compare the change of the potency in various storage temperatures and duration and, to determine the optimal conditions for storage of botulinum toxin without potency reduction. METHODS: The potency of botulinum toxin was measured by the reduction rate of tension of the injected gastrocnemius muscle of Sprague-Dawley rats. The potency of botulinum toxin could be estimated through the comparison of the reduction rate of tension between two muscles; botulinum toxin injected muscle and normal saline injected control muscle, which was denoted as % paralysis. RESULTS: Botulinum toxin induced muscle paralysis in a dose-dependent manner. Muscle was paralysed by 9.8+/-0.6(mean+/-standard error), 10.2+/-2.7, 38.3+/-13.6, and 93.7+/-0.5% at 0(injected normal saline to both sides of gastrocnemius muscles of the same rat), 0.01, 0.1, and 1unit/0.1ml of fresh botulinum toxin injection, respectively. Percent paralyses by 1unit/0.1ml of stored botulinum toxin at 4degreeC and -20degreeC were 98.8+/-0.6% and 98.2+/-0.9% in 4 weeks, respectively. Percent paralyses by 0.1 unit/0.1 ml of stored botulinum toxin at 4degreeC and -20degreeC were 29.6+/-4.8% and 35.5+/-15.1% in 4 weeks, respectively. CONCLUSION: With these findings, the authors proved that if botulinum toxin is stored in refrigerator(4degreeC) or refreezer(-20degreeC) after reconstruction, it can be used without the decrease of its potency.

Keyword

Botulinum toxin; Potency; Storage temperature; Storage duration

MeSH Terms

Botulinum Toxins*
Humans
Muscle, Skeletal
Muscles
Paralysis
Rats, Sprague-Dawley
Research Personnel
Botulinum Toxins
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