Pharmaceutical composition comprising botulinum, a non ionic surfactant, sodium chloride and sucrose
The invention relates to a solid or liquid pharmaceutical composition comprising botulinum neurotoxin complex (type A, B, C, D, E, F or G) or high purity botulinum neurotoxin (type A, B, C, D, E, F or G), and a surfactant. In particular the invention relates to a solid or liquid pharmaceutical composition comprising a crystalline agent.
1. A liquid pharmaceutical composition consisting of
(a) botulinum toxin complex type A,
(b) 0.01% (v/v) POLYSORBATE 80 (polyoxyethylene (20) sorbitan monooleate),
(c) 0.15 M sodium chloride,
(d) 10 mM histidine to maintain the pH at 6.5,
(e) 11.7 mM sucrose, and
(f) sterile water.
2. The liquid pharmaceutical composition according to claim 1 , wherein the concentration of the botulinum toxin complex type A is 500 LD 50 units.
3. The liquid pharmaceutical composition according to claim 1 , wherein said composition is sealed in a syringe device with no liquid/gaseous interface.
4. A liquid pharmaceutical composition consisting of
(a) 100 to 2,000 LD 50 units botulinum toxin complex type A,
(b) 0.005% to 0.02% (v/v) POLYSORBATE 80 (polyoxyethylene (20) sorbitan monooleate),
(c) 0.15 to 0.3 M sodium chloride,
(d) 5 to 20 mM histidine to maintain the pH at 5.5 to 7.5,
(e) 10 to 20 mM sucrose, and
(f) sterile water.