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ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ HGH И RHIGF-1
专利权人:
ИПСЕН ФАРМА С.А.С. (FR)
发明人:
ГОПИНАТ Энона (US),ПАРК Сьюзан (US),АРАКАВА Цутому (US),РИШАР Жоэль (FR),ФЭ Фабио (FR)
申请号:
RU2012124985/15
公开号:
RU2012124985A
申请日:
2010.11.17
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A pharmaceutical composition comprising IGF-1 and GH and- A means of warning the aggregation- Buffer- surface-active substance- Optionally, a preservative and- Optionally, a tonicity modifier or filler,wherein the means to prevent an aggregation, is present in the composition at a concentration of at least about 80 mM.2. A pharmaceutical composition according to claim 1, wherein the means to prevent an aggregation represents arginine (arginine ion) or lysine.3. A pharmaceutical composition according to claim 2, wherein the means to prevent an aggregation is arginine in a concentration of about 80-200 mM, preferably about 100-150 mM.4. A pharmaceutical composition according to any one of claims 1-3, wherein the buffer is selected from histidine, citrate or succinate at a concentration of about 1-50 mM, preferably about 10-20 mM.5. A pharmaceutical composition according to claim 1, wherein the surfactant is a nonionic surfactant.6. A pharmaceutical composition according to claim 5 wherein the nonionic surfactant is polysorbate 20 at a concentration of about 0.1-0.3% by weight, preferably about 0.2% by weight.7. A pharmaceutical composition according to claim 5, wherein the non-ionic surfactant is poloxamer 188 at a concentration of about 0.1-0.5% by weight, preferably about 0.3%.8. A pharmaceutical composition according to claim 1 wherein the tonicity modifier is sodium chloride.9. A pharmaceutical composition according to claim 1, wherein the filler is mannitol and / or sucrose.10. A pharmaceutical composition according to claim 8, wherein the tonicity modifier is sodium chloride at a concentration of about 1-50 mM.11. The pharmaceutical composition of claim 1 wherein the preservative is benzyl alcohol or phenol.12. A pharmaceutical composition according to claim 11, wherein said preservative is benzyl alcohol at a concentration of about 0.2-2% by weight, preferably about 1%.13. The pharmaceutical composition of claim 1 wherein the weight ratio IGF-1 to mass of GH
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