Xeomin® is stable without refrigeration: Complexing proteins are not required for stability of botulinum neurotoxin type A preparations
2008; Elsevier BV; Volume: 51; Linguagem: Inglês
10.1016/j.toxicon.2008.04.038
ISSN1879-3150
AutoresSwen Grein, Gerd J. Mander, Harold V. Taylor,
Tópico(s)Cancer Treatment and Pharmacology
ResumoNative botulinum toxin type A (BTX-A) is a high molecular weight complex of about 900 kDa, composed of the biologically active 150 kDa neurotoxin, several hemagglutinins, and other nontoxic proteins. Although these complexing proteins do not have any therapeutic effect, it has been speculated that they might be required for stability of botulinum neurotoxin type A preparations. Xeomin® is a botulinum neurotoxin type A preparation, which, unlike other marketed BTX-A products, contains only the pure 150 kDa neurotoxin without complexing proteins. The stability of Xeomin® was assessed in comprehensive real-time and accelerated stability studies according to ICH guidelines. The study results showed no detrimental effects on the quality of Xeomin® after storage of up to 40 °C, and have accounted for its shelf-life of 3 years without the need for refrigeration. In a further temperature stress study, samples of Xeomin® were stored above 40 °C. As in the ICH-conform stability studies, the samples were tested with fully validated or standardized pharmacopoeia analytical methods also used for release testing of Xeomin®. The results demonstrate that Xeomin® is not negatively affected by storage at temperatures between 40 and 60 °C for up to 1 month. Altogether, these findings provide clear evidence that the complexing proteins in pharmaceutical preparations of botulinum neurotoxin A are not required for stability.
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