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STABLE PHARMACEUTICAL COMPOSITION BASED ON FUSED PROTEIN TNFR: FC
专利权人:
ЛЮПИН ЛИМИТЕД (IN)
发明人:
АПТЕ-ДЕШПАНДЕ Анджали Деепак (IN),ДЕОКАР Ваибхав Дьянешвар (IN),МОДИ Рустом Сораб (IN)
申请号:
RU2015119603
公开号:
RU2015119603A
申请日:
2013.10.24
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. A stable pharmaceutical composition comprising a TNFR: Fc fusion protein and a phosphate-citrate buffer. The composition of claim 1, wherein the pH of the composition is in the range of 5 to 3. The composition of claim 1, wherein the TNFR: Fc fusion protein is etanercept. 4. The composition of claim 1, wherein the composition is sterile and ready for parenteral administration. The composition of claim 4, wherein the composition is liquid. The composition of claim 4, wherein the composition is lyophilized. A stable pharmaceutical composition comprising a TNFR: Fc fusion protein, a phosphate citrate buffer, and an aggregation inhibitor selected from the group consisting of L-glycine, urea, and 2-hydroxypropyl-beta-cyclodextrin (HPBCD) .8. The composition of claim 7, wherein the pH of the composition is in the range of 5 to 9. The composition of claim 7, wherein the TNFR: Fc fusion protein is etanercept. The composition of claim 7, wherein the composition is sterile and ready for parenteral administration. The composition of claim 10, wherein the composition is liquid. The composition of claim 10, wherein the composition is lyophilized. A stable pharmaceutical composition comprising a TNFR fusion protein: Fc, phosphate citrate buffer, an aggregation inhibitor selected from L-glycine, urea and 2-hydroxypropyl beta-cyclodextrin (HPBCD), a tonicity regulating agent and a stabilizing agent. 14 . The composition of claim 13, wherein the tonicity control agent is selected from the group of salts including sodium chloride, potassium chloride, calcium chloride; a group of saccharides, including mannitol, sucrose, glucose, and amino acids. 15. The composition of claim 13, wherein the stabilizing agent is selected from the group consisting of sucrose and trehalose. A stable pharmaceutical composition according to claim 13, containing etanercept as1. Стабильная фармацевтическая композиция, содержащая слитый белок TNFR:Fc и фосфатно-цитратный буфер.2. Композиция по п. 1, где зн
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