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STABLE LIQUID PHARMACEUTICAL DRUGS OF THE TNFR FUSED PROTEIN: Fc
专利权人:
САНДОЗ АГ (CH)
发明人:
ДОЙТЕЛЬ Бритта (AT),ЛАУБЕР Томас (AT),ФЮРТИНГЕР Забине (AT)
申请号:
RU2013151303/10
公开号:
RU2013151303A
申请日:
2012.04.19
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A pharmaceutical composition comprising TNFR: Fc, a citrate buffer, and an amino acid selected from the group consisting of lysine and proline and their pharmaceutically acceptable salts. The pharmaceutical composition according to claim 1, containing citrate buffer at a concentration of from 25 to 120 mm. The pharmaceutical composition according to claim 1 or 2, comprising an amino acid in a concentration of from 15 to 100 mM, wherein the amino acid is preferably lysine or a pharmaceutically acceptable salt thereof. The pharmaceutical composition according to claim 1 or 2, further comprising a tonicity modifier, wherein the tonicity modifier is preferably selected from the group consisting of sodium chloride, cysteine, histidine, glycine, potassium chloride, sucrose, glucose and mannitol, more preferably the tonicity modifier is sodium chloride and / or sucrose. 5. The pharmaceutical composition according to claim 4, containing at least one tonicity modifier in a total concentration of from 5 to 200 mm. The pharmaceutical composition according to claim 1 or 2, additionally containing at least one excipient, where at least one excipient is preferably selected from the group comprising lactose, glycerin, xylitol, sorbitol, mannitol, maltose, inositol, trehalose, glucose, bovine serum albumin (BSA), dextran, polyvinyl acetate (PVA), hydroxypropylmethyl cellulose (HPMC), polyethyleneimine (PEI), gelatin, polyvinylpyrrolidone (PVP), hydroxyethyl cellulose (HEC), polyethylene glycol (PEG), ethylene glycol, dimethyl sulfide (DMF) L-serine, g utamat sodium, alanine, glycine, sarcosine, gamma-aminobutyric acid (GABA), polyoxyethylene sorbitan monolaurate, preferably Tween 20, polioksietilensorbitanmonoole1. Фармацевтическая композиция, содержащая TNFR:Fc, цитратный буфер и аминокислоту, выбранную из группы, включающей лизин и пролин и их фармацевтически приемлемые соли.2. Фармацевтическая композиция по п.1, содержащая цитратный буфер в концентрации от 25 до 120 мМ.3. Фар
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