Produced by Clostridium botulinum, botulinum toxins are high molecular weight protein complexes consisting of the neurotoxin and additional nontoxic proteins that function to protect the toxin molecule. The neurotoxin acts to inhibit the release of acetylcholine at the neuromuscular junction, causing muscle paralysis. Purified toxin complexes have found a niche in the treatment of clinical disorders involving muscle hyperactivity. The different serotypes are structurally and functionally similar; however, specific differences in neuronal acceptor binding sites, intracellular enzymatic sites, and species sensitivities suggest that each serotype is its own unique pharmacologic entity. Recently, botulinum toxin type B has been developed as a liquid formulation to avoid the lyophilization (vacuum-drying) and reconstitution processes associated with decreasing the potency and stability of current type A toxin preparations. Biochemical tests were conducted to evaluate the quality of toxin in this formulation. In 3 consecutive manufacturing lots, the botulinum toxin type B complex was found to be highly purified, intact, uniform, and consistent from lot to lot. Also, it showed long-term stability at refrigerator and room temperatures (2 to 25°C). Electrophysiologic studies in cynomolgus monkeys showed that botulinum toxin type B is effective in paralyzing injected muscle groups, with minimal spread to relatively distant noninjected muscles.
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