Xeomin super(()R) is stable without refrigeration: Complexing proteins are not required for stability of botulinum neurotoxin type A preparations

• Published in: Toxicon (Oxford) Vol. 51; p. 13
• Main Authors: Grein, S, Mander, G J, Taylor, H V
• Format: Journal Article
• Language: English
• Published: 01.06.2008
• ISSN: 0041-0101
• DOI: 10.1016/j.toxicon.2008.04.038

Native botulinum toxin type A (BTX-A) is a high molecular weight complex of about 900kDa, composed of the biologically active 150kDa 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 super(()R) is a botulinum neurotoxin type A preparation, which, unlike other marketed BTX-A products, contains only the pure 150kDa neurotoxin without complexing proteins. The stability of Xeomin super(()R) 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 super(()R) after storage of up to 40 super(o)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 super(()R) were stored above 40 super(o)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 super(()R). The results demonstrate that Xeomin super(()R) is not negatively affected by storage at temperatures between 40 and 60 super(o)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.