ROBERT MUELLER,PIERRE GOLDBACH,HANNS-CHRISTIAN MAHLER
申请号：
ARP130100743
公开号：
AR090272A1
申请日:
2013.03.07
申请国别(地区):
AR
年份:
2014
代理人:
摘要：
Claim 1: a stable Liquid Pharmaceutical formulation containing Antibody: approx. 50 mg / ml 200 mg / ml of an Antibody AB, approx. From 0.01% to 0.1% of poloxamer, with preference of the Poloxamer 188, approx. 5 mm to 50 mm of a tampon, approx. From 100 mm to 300 mm, a Stabilizing Agent, a pH approx. Between 4.5 and 7.0.Claim 7: pharmaceutical formulation of claims 1 to 6, the Stabilizer is selected between Sugars and amino acids. Claim 8: pharmaceutical formulation of claim 7, the Stabilizer is selected between Trehalose and arginine.Claim 12: pharmaceutical formulation of claims 1 to 10, in which the Antibody is a monoclonal AB that has a long chain and short chain.Claim 18: pharmaceutical formulation of Claims 11 to 16, which is a mixture of monoclonal antibody Ab Ab Ab biglicosilados monoglicosilados Antibodies and Antibodies, the Antibody monoglicosilado contains a glycosylated asparagine (ASN) at position 52 The seq. Id.No. 2 in the VH domain of a Binding Site of the Antibody and the Antibody biglicosilado contains a glycosylated asparagine (ASN) at position 52 of the seq. ID no. 2 in the VH domain of the two binding sites of the Antibody and the mixture contains less than 5% of a non glycosylated Antibody at position 52 of the seq. ID no. 2 in the VH domain.Reivindicación 1: Una formulación farmacéutica líquida estable de anticuerpo que contiene: aprox. de 50 mg/ml a 200 mg/ml de un anticuerpo Ab, aprox. del 0,01 % al 0,1% de un poloxámero, con preferencia del poloxámero 188, aprox. de 5 mM a 50 mM de un tampón, aprox. de 100 mM a 300 mM de un estabilizante, de un pH comprendido aprox. entre 4,5 y 7,0. Reivindicación 7: La formulación farmacéutica de las reivindicaciones de 1 a 6, cuyo estabilizante se elige entre azúcares y aminoácidos. Reivindicación 8: La formulación farmacéutica de la reivindicación 7, cuyo estabilizante se elige entre trehalosa y arginina. Reivindicación 12: La formulación farmacéutica de las reivindicaciones de 1 a 10, en la que el an
