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STABLE MULTI-DOSE COMPOSITIONS CONTAINING ANTIBODY AND CONSERVANT
专利权人:
НОВО НОРДИСК А/С (DK)
发明人:
ПАРШАД Хенрик (DK),ЭНГЕЛУНД Дорте Кот (DK)
申请号:
RU2012153786/10
公开号:
RU2012153786A
申请日:
2011.05.26
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A stable multi-dose liquid composition comprising an antibody and one or more than one preservative. The composition according to claim 1, wherein the preservative is present in the composition in an amount of from 0.001 to 2% (weight / volume), for example, from 0.002 to 1% (weight / volume). The composition according to claim 1, where one or more than one preservative is selected among phenol, m-cresol, benzyl alcohol, chlorobutanol, ethanol, phenoxyethanol, p-chloro-m-cresol, methylparaben, propylparaben, benzalkonium chloride, thiomersal, or any combination thereof e.g. phenol, m-cresol, benzyl alcohol and chlorobutanol. 4. The composition according to claim 1, which contains one preservative selected from phenol, m-cresol, benzyl alcohol, chlorobutanol, ethanol, phenoxyethanol, p-chloro-m-cresol, methylparaben, propylparaben, benzalkonium chloride and thiomersal, for example phenol, m- cresol, benzyl alcohol and chlorobutanol. 5. The composition according to claim 1, which contains two or more two preservatives selected from phenol, m-cresol, benzyl alcohol, chlorobutanol, ethanol, phenoxyethanol, p-chloro-m-cresol, methylparaben, propylparaben, benzalkonium chloride, thiomersal or any of them combinations, in particular phenol and m-cresol; benzyl alcohol and chlorobutanol. 6. The composition according to claim 1, which is buffered to a pH of from 5 to 7, for example to a pH of from 6.0 to 7.0, for example 6.0 or 6.5, in particular 6.5.7. A composition according to claim 1, which further comprises a tonicity modifying agent, such as sucrose or propylene glycol. The composition of claim 1, wherein the antibody is present in the composition at a concentration of 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250, or 300 mg / ml. The composition of claim 1, wherein the surfactant is absent. The composition according to claim 1, which includes: (A1. Стабильная многодозовая жидкая композиция, содержащая антитело и один или более чем один консервант.2. Ко
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