ADLER, MICHAEL,MAHLER, HANNS-CHRISTIAN,STAUCH, OLIVER BORIS
申请号：
RSP20160354
公开号：
RS54769B1
申请日:
2010.09.10
申请国别(地区):
RS
年份:
2016
代理人:
摘要：
Claim 1: a stable Pharmaceutical formulation, very concentrated, an anti-cd20 Antibody containing pharmaceutically Active): approx. From 50 to 350 mg / ml of anti-cd20 Antibody； b) approx. From 1 to 100 mm of a buffering Agent to maintain the pH 5.5 + - 2.0； c) approx. 1 500 mm of a Stabilizer or a mixture of two or more stabilizers； (d) approx.From 0.01 to 0.1% of non ionic surfactant； and (e) optionally, an effective amount of at least one Enzyme hyaluronidase. Claim 2: a stable Pharmaceutical formulation, very concentrated, the anti-cd20 Antibody according to any one of claims 1 to 5, in which the Agent is a histidine buffer buffer.Claim 7: a stable Pharmaceutical formulation, very concentrated, the anti-cd20 Antibody according to any one of claims 1 to 6, in which the Stabilizer is a saccharide, e.g. Alpha, Alpha Trehalose Dihydrate or sucrose.Claim 7: a stable Pharmaceutical formulation, very concentrated, the anti-cd20 Antibody according to claim 7 or 8, in which the second methionine is used as Stabilizer. Claim 1.A stable Pharmaceutical formulation, very concentrated, the anti-cd20 Antibody according to any one of claims 1 to 10, where a Polysorbate nonionic Surfactant is preferably selected from the group consisting of Polysorbate 20, Polysorbate 80 and a COPOLYMER Polyethylene, polypropylene.Claim 1: a stable Pharmaceutical formulation, very concentrated, the anti-cd20 Antibody according to any one of claims 1 to 13, which is the anti-cd20 Antibody rituximab.Claim 1: a stable Pharmaceutical formulation, very concentrated, the anti-cd20 Antibody according to any one of claims 1 to 13, in which the anti-cd20 Antibody ocrelizumab is.Visoko koncentrisana, stabilna farmaceutska formulacija za subkutano primenjivanje farmaceutski aktivnog anti-CD20 antitela, koja sadrži:a. 50 do 350 mg/ml anti-CD20 antitela；b. 1 do 100 mM puferskog sredstva koje obezbeđuje pH od 5.5 ± 2.0；c. 1 do 500 mM stabilizatora ili mešavine dva ili više stabilizatora；d. 0.01 do 0.1 % nejo
