Others BoNT
data9 . Scientists from Merz Aesthetics have now shown
that all the BoNT products contain free-BoNT neurotoxin in the vials; none are associated with complex. The myth that different BoNT complexes exist in the products has finally been driven away9 The units of each product are specific to that
.
product and are not directly interchangeable. In accordance with the terms of their marketing authorisations, manufacturers are not permitted to give equivalent dose conversion factors. The use of the official reconstitution volumes, as included for each product in their Summary of Product Characteristics (SPC), has been specifically developed for the products from evidence-based clinical trials and so, clinicians will benefit (especially from a large data base of supporting information) when using those recommendations.
Onset of action Patient satisfaction comes in many forms.
Some
aspects can be directly assessed with patients, as discussed later; but others are perhaps more subtle, such as the speed at which the result may appear. Many patients go for BoNT treatment expecting (and wanting) a rapid effect. They are going to a wedding or a special occasion, and their friends have only just persuaded them to go for a treatment, to look their best on a special day. No-one had really looked at how fast a BoNT product
worked after injection. For decades, the thinking on how long a BoNT product took to work was that nothing could be seen until 7 days after an injection. There are many studies on both aesthetic and medical applications, even in controlled clinical trials, that have the first study time point as 7 days. In 2009, however, our knowledge changed significantly. New data
comple“The myth that different BoNT ”
has finally been driven away. Asia BoNT
North America BoNT
Europe BoNT
Figure 1 Distribution of BoNT aesthetic use in the world, 2011. Based on data presented by Medical Insights, Inc. at IMCAS 2012, Paris
Table 1. Current major BoNT product characteristics Product
Product strain Process Dysport® Hall AZZALURE® Hall
BOTOX®/ BOTOX® Cosmetic
& Vistabex® Xeomin® Chromatography
Fermentation 125 Dialysis
Chromatography
Allergan ‘hyper’ Fermentation 100 Precipitation ‘Crystallisation’
Vistabel® Allergan ‘hyper’ Fermentation 50 Precipitation ‘Crystallisation’
Hall Bocouture® Hall [Unpublished] 100 [Unpublished] 50 HSA 500 m g HSA 500 m g HSA NaCl 0.9 mg NaCl 0.9 mg Sucrose
1 mg 5 mg HSA
1 mg 5 mg HSA = Human Serum Albumin stabiliser xes exist in the products
The parent product of each family (Dysport®, BOTOX® and Xeomin®) are the oldest licensed products from each of the manufacturers. The aesthetic versions (AZZALURE®, Vistabel®/Vistabex® and Bocouture®) are the versions sold only within the European Community only with lower dose vials specifically intended for aesthetic use, one vial per patient. Not all aesthetic version products are yet registered in all European countries. All the aesthetic versions are identical to the parent product except for the number of units per vial.
© 2012 Toxin Science Limited. Reproduced with permission.
prime-journal.com | March 2012 ❚ Sucrose HSA [Speywood] 125 m g
Lactose 2.5 mg
U/vial [product specific]
Fermentation 500 Dialysis
[Speywood]
Excipients (in vial)
HSA 125 m g
Lactose 2.5 mg
89
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