Published online by Cambridge University Press: 28 July 2009
Introduction
Botulinum toxin (BT) drugs consist of a complex mixture of substances. All of those components can differ between BT drugs. Therapeutically the most important difference refers to the botulinum neurotoxin (BNT) serotype used. So far, only types A and B are commercially available, whereas types C and F have been tried in humans on an experimental basis only. Types A and B have a substantially different affinity to the motor and to the autonomic nervous system (Dressler & Benecke, 2003). Other ingredients can also vary. The pH 5.4 buffer system of NeuroBloc®/Myobloc® increases the injection site pain as compared to all other BT drugs using pH 7.4 buffer systems. Hengli® is the only BT drug applying gelatine stabilization, which may cause allergic reactions. Other differences in protein content may affect tissue perfusion and antigenicity. Clearly, the commercially available BT drugs are not identical. Some of their differences matter therapeutically, others, however, seem not to matter. Contrary to a commercially biased belief BT drugs can be compared and should be compared. “Uniqueness” does not exist amongst BT drugs, whereas differentiation does.
Structure
As shown in Figure 3.1, BT drugs consist of the BT component and excipients. Excipients include lactose, sucrose, and serum albumin for stabilization purposes and buffer systems for pH calibration. The BT component is formed by BNT and by non-toxic proteins also known as complexing proteins.
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