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 solid or liquid pharmaceutical composition consisting of:
(a) botulinum neurotoxin complex of type A, B, C, D, E, F or G, or a high purity botulinum neurotoxin of type A, B, C, D, E, F or G;
(b) a non-ionic surfactant;
(c) sodium chloride;
(d) a buffer capable of maintaining an aqueous solution at a pH of 5.5 to 7.5;
(e) a disaccharide; and
(f) when the composition is liquid, water,
wherein the composition does not contain albumin or polysaccharides.
2. The composition of claim 1 , wherein the botulinum neurotoxin complex is type A.
3. The composition of claim 1 , wherein the high purity botulinum neurotoxin is type A.
4. The composition of claim 1 , wherein the botulinum neurotoxin is present at 50 to 3,000 LD50 units.
5. The composition of claim 1 , wherein the non-ionic surfactant is a polysorbate.
6. The composition of claim 5 , wherein the polysorbate is polyoxyethylene (20) sorbitan monooleate.
7. The composition of claim 1 , wherein the disaccharide is sucrose, trehalose or lactose.
8. The composition of claim 7 , wherein the disaccharide is sucrose.
9. The composition of claim 1 , wherein the buffer is succinate or histidine.
10. The composition of claim 9 , wherein the buffer is histidine.
11. The composition of claim 1 , wherein the buffer is capable of maintaining an aqueous solution at a pH of 5.8 to 7.0.
12. The composition of claim 1 , wherein the composition is a solid pharmaceutical composition.
13. The composition of claim 1 , wherein the composition is a liquid pharmaceutical composition.
14. The composition of claim 13 , wherein the non-ionic surfactant is present in an amount of from above critical micellar concentration to 1% v/v of the total volume of the composition.
15. The composition of claim 13 , wherein the non-ionic surfactant is polysorbate 80 and is present in an amount of from 0.005% to 0.02% v/v of the total volume of the composition.
16. The composition of claim 13 , wherein the concentration of sodium chloride is from 0.1 to 0.5 M.
17. The composition of claim 13 , wherein the disaccharide is present in a concentration of from 5 to 50 mM.
18. The composition of claim 13 , wherein the concentration of the buffer is from 1 to 50 mM.