Freeze-dried dosage preparations containing botulinum toxin and methods of preparation

Abstract

The invention relates to a freeze-dried botulinum toxin formulation capable of long-term preservation, comprising botulinum toxin, protamine sulfate, isotonic and buffering agents, and a freeze-dried botulinum toxin formulation according to the invention that reduces the rate of deactivation of botulinum toxin during freeze-drying, capable of maintaining the stability of botulinum toxin for longer than conventional freeze-dried botulinum toxin formulations. The invention aims to create a uniformly sized particle to ensure consistent efficacy at the site of application and to prevent side effects, such as the toxic effect manifesting only at certain sites. The invention also relates to a method for preparing a frozen botulinum toxin formulation.