STABLE LIQUID FORMULATION OF BOTULINUM TOXIN

摘要

PROBLEM TO BE SOLVED: To provide a ready-to-use liquid formulation for use of a botulinum toxin that is easily transported, stored and used.

SOLUTION: A composition is for treating a patient who needs to check a cholinergic input to selected muscles, muscle clusters, glands or organs. The composition contains the ready-to-use, stable, pharmaceutical liquid formulation of the botulinum toxin for use of a pharmaceutically effective dosage. The formulation includes (a) pharmaceutically acceptable buffered physiological saline containing a buffer component selected from the group consisting of a phosphoric acid buffer, a phosphoric acid-citric acid buffer and a succinic acid buffer; (b) serum albumin; (c) the isolated botulinum toxin. The composition is stable as a liquid for at least an year at a temperature of ±10% of a temperature between 0-10°C or for at least 6 months at a temperature of ±10% of a temperature between 10-30°C. The composition is suitable for administration as a pharmaceutical agent to mammals without reconstruction.

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