| Autor: |
Orbegozo, P., Gore, N., Calderwood, T., Venteicher, R., Callaway, J., Grethlein, A. |
| Předmět: |
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| Zdroj: |
European Journal of Neurology; Jul2001 Supplement 4, Vol. 8, p26-26, 1p |
| Abstrakt: |
Introduction Botulinum toxins have proven efficacy and safety for treating cervical dystonia. The consistency of clinical benefit among patients, however, is affected by various factors, including the stability of the toxin formulation. The present study investigates the stability of NeuroBloc™, a liquid formulation of the B serotype, at 2-8 °C and, importantly, at room temperature (25 °C) in the longer term. Methods The mouse intraperitoneal LDs0 potency assay was used to measure NeuroBloC stability. The test sample was prepared in a dilution series based on target potency. Eight mice were used per dilution, five dilutions (levels) per test, and five tests per assay. Mice were observed daily for 4 days postinjection. Results There was no significant change in product potency under either storage condition. Storage at 2-8 °C: mean potency after 12 months was 103% of target (range 92-111%; nine lots), and after 30 months was 92% of target (range 86-98%; three lots). Storage at 25 °C: after 6 months, mean potency was 100% of target (range 82-114%; nine lots). All these final results are within acceptable product-release specifications. Conclusions NeuroBloC retains potency for at least 30 months when refrigerated (2-8 °C) and for at least 6 months at room temperature (25 °C). The extraordinary stability of the liquid formulation of NeuroBloC may contribute to improved consistency in clinical outcomes. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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