STABLE LIQUID FORMULATION OF BOTULINUM TOXIN

摘要

PROBLEM TO BE SOLVED: To provide a ready-to-use liquid formulation of botulinum toxin that can be conveniently shipped, stored and used as needed.SOLUTION: A composition is for treating a patient in need of inhibition of cholinergic transmission to selected muscle or muscle group or a gland or an organ. The composition contains a stable liquid pharmaceutical botulinum toxin formulation prepared for the use of pharmaceutically effective dosage, the formulation containing: (a) a pharmaceutically acceptable buffered physiological saline containing a buffering component selected from a phosphate buffer solution, a phosphate-citrate buffer solution and succinate buffer solution; (b) serum albumin; and (c) isolated botulinum toxin. The composition is stable as a liquid for at least 1 year at a temperature of ±10% of a temperature between 0°C and 10°C or stable as a liquid for at least 6 months at a temperature of ±10% of a temperature between 10°C and 30°C, and the composition is suitable for the administration as a medicine to mammals without necessitating further reconstitution.