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TEST FOR THE HEMOLITIC POTENTIAL OF PHARMACEUTICAL PRODUCTS AND COMPOSITIONS FOR MINIMIZING RISK
专利权人:
ОКТАФАРМА АГ (CH)
发明人:
ХЕГЕР Андреа (AT),СВАЕ Тор-Эйнар (AT),РЕМИШ Юрген (AT),ЦЕХЛИНГ Альфред (AT)
申请号:
RU2015115649
公开号:
RU2015115649A
申请日:
2013.09.26
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. Non-hemolytic acid composition containing an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH in the range from 4.65 to 5.7, containing one or more excipients selected from amino acids, sugars, sugar alcohols in a concentration range of 100 -350 mmol / L, in particular 200-350 mmol / L, characterized in that it displays an optical density (OD) in the range from 0.14 to -0.1 when the OD is determined in a spectrophotometer at 414 nm and a film thickness of 0.825 mm. 2. The non-hemolytic acid composition according to claim 1, wherein the excipients are selected from glycine, L-proline, arginine, histidine, D-sorbitol, mannitol, maltose and sucrose. 3. Non-hemolytic acid composition according to claims 1 and 2, having an osmolality in the range of 200-400 mOsmol / kg, in particular 230-350 mOsmol / kg. 4. A pharmaceutical composition comprising a non-hemolytic acid composition according to any one of paragraphs. 1-3 and a pharmaceutically acceptable carrier. 5. The pharmaceutical composition of claim 4, wherein the immunoglobulin is immunoglobulin G.6. The pharmaceutical composition according to PP. 4 and 5, where the immunoglobulin G is made for subcutaneous, intravenous or intramuscular administration. The pharmaceutical composition of claim 6 for the treatment of immunodeficiencies, such as X-linked agammaglobulinemia, hypogammaglobulinemia, acquired weakened immune conditions (secondary immunodeficiencies) associated with low levels of antibodies, autoimmune diseases, for example, ITP immune thrombocytopenia, and inflammatory diseases, for example , chronic demyelinating polyneuropathy (CIDP), and neurological diseases such as multifocal motor neuropathy, myasthenia gravis, and multiple sclerosis. 8. Application1. Негемолитическая кислотная композиция, содержащая иммуноглобулин, выбранный из иммуноглобулина А, иммуноглобулина G или иммуноглобулина М при величине рН в диапазоне от 4,65 до 5,7, содержащая один или более э
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