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Formulation of neurotoxins
专利权人:
IPSEN BIOPHARMA LIMITED
发明人:
申请号:
ARP170101464
公开号:
AR108631A1
申请日:
2017.05.29
申请国别(地区):
AR
年份:
2018
代理人:
摘要:
Stable Liquid formulations of neurotoxins that are free of Animal Protein, comprising a Surfactant, an amino acid selected from tryptophan and tyrosineA buffer which comprises Sodium ions, chloride and phosphate, with a pH between 5.5 and 8 and are stable for 2 months.These compositions are suitable for use in therapy, in particular for Administering to a patient in order to achieve a desired therapeutic effect or Aesthetic.Refers to the use of selected amino acid tryptophan and tyrosine to protect a Neurotoxin protein\u00e1cea of degradation in a Liquid composition which is free of Protein derived dAnd animals.Claim 1: a Liquid composition comprising a protein\u00e1cea Neurotoxin, a Surfactant, an amino acid selected from tryptophan and tyrosine, which comprises a buffer Sodium ionsChloride and phosphate, where the liquid composition has a pH between 5.5 and 8Where the composition is free of Proteins derived from Animals and where the liquid composition is stable over time.Claim 8: a Liquid composition according to any one of claims 1 to 7, where the protein\u00e1cea is a Neurotoxin botulinum Neurotoxin,Selected natural a botulinum Neurotoxin botulinum Neurotoxin Complex shape, high purity natural and recombinant botulinum Neurotoxin.Claim 9: a Liquid composition according to claim 8Where this is a recombinant botulinum Neurotoxin botulinum Neurotoxin botulinum Neurotoxin Selected A, B, C, D, e, F or g,A modified botulinum Neurotoxin botulinum Neurotoxin and a chimerical.Claim 10: a Liquid composition according to any one of claims 1 to 9,Where the liquid composition includes: 4 LD50 to 10000 units per ml of botulinum Neurotoxin, 0.001 to 15% V \/ V of Polysorbate, 0.1 to 5 mg \/ ml of tryptophan, 10 to 500 mM NaCl.1 to 50 mM KCl, 1 mm to 100 mm Sodium Phosphate, has a pH between 5.5 and 8 and is stable for 6 months to 40.Claim 1: a Liquid composition according to claim 10, wherein Said Liquid composition comprises: 10 LD50 to 2000 units per ml of botulinum Neuroto
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