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Last Updated: March 28, 2024

Claims for Patent: 9,125,804


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Summary for Patent: 9,125,804
Title:Pharmaceutical composition comprising botulinum, a non ionic surfactant, sodium chloride and sucrose
Abstract: 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.
Inventor(s): Webb; Paul (Wrexham, GB), White; Mary (Wrexham, GB), Partington; Julie (Wrexham, GB)
Assignee: IPSEN BIOPHARM LIMITED (Wrexham, GB)
Application Number:11/632,156
Patent Claims: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.sub.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.sub.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.

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