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IMPROVED COMPOSITIONS OF RECOMBINANT HUMAN LIPASE STIMULATED BY BALIC ACID SALTS
专利权人:
СВЕДИШ ОРФАН БИОВИТРУМ АБ (ПАБЛ)
发明人:
ЭК Вильхельм
申请号:
RU2014116256
公开号:
RU2014116256A
申请日:
2012.09.25
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A composition suitable for lyophilization, comprising: (i) a recombinant human lipase stimulated with bile salts (rhBSSL); (ii) a crystalline excipient and (iii) an amorphous stabilizer that is a different chemical compound than the indicated crystalline excipient and is present in a relative amount between about 0.1 and about 0.5 mg per 1 mg of said rhBSSL. 2. The composition of claim 1, wherein said amorphous stabilizer is selected from the group consisting of: L-arginine; L-histidine; L-proline; L-alanine and glycine. 3. The composition of claim 2, wherein said amorphous stabilizer is glycine 4. The composition of claim 1, wherein said amorphous stabilizer is present at a concentration of between 10 and 100 mM. The composition of claim 4, wherein said amorphous stabilizer is present at a concentration of between 35 and 50 mM. The composition according to claim 1, wherein said crystalline filler is mannitol. 7. A composition according to claim 1, wherein said crystalline filler is present in a concentration between 100 and 400 mM. The composition of claim 7, wherein said crystalline filler is present at a concentration of between 180 and 210 mM. The composition of claim 1, wherein said rhBSSL is present at a concentration between 1 and 35 mg / ml. The composition of claim 9, wherein said rhBSSL is present at a concentration of between 10 and 15 mg / ml. The composition of claim 10, comprising: (i) rhBSSL at a concentration of between 10 and 15 mg / ml; (ii) mannitol at a concentration of between 180 and 210 mM; and (iii) glycine in a concentration between 35 and 50 mM; 12. The composition according to claim 1, having a pH value between 6.3 and 7.5.13. The composition of claim 1, further comprising sodium phosphate in a phosphate concentration between 2 and 20 mM. A composition according to claim 1, further comprising sodium chloride in a chloride concentration between 5 and 50 mM. Lyophilized1. Состав, подходящий для лиофилизации, содержащий:(i) рекомбинантную
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