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1. Formulation of stable antibody against PD-1 and its use
专利权人:
MERCK SHARP and DOHME CORP.
发明人:
SHARMA, Manoj K.,BENJAMIN, Wendy,MITTAL, Sarita,BASARKAR, Ashwin,NARASIMHAN, Chakravarthy Nachu,KASHI, Ramesh S.,SHAMEEM, Mohammed,BHATTACHARYA, Soumendu,FORREST, JR., William P.,KRISHNAMACHARI, Yogit
申请号:
PE2019002280
公开号:
PE20200513A1
申请日:
2018.05.01
申请国别(地区):
PE
年份:
2020
代理人:
摘要:
A formulation of a human anti-PD antibody comprises: (a) about 5-200 mg / ml of human anti-PD-1 antibody, or a polymer of the antibody; (b) a buffer of about 5-20 mm; (c) a stabilizer selected from (1) about 6-8% of P / V sugar, trihalogens, etc. (2) or (c) about 6-8% of sugar and trihalogens. Manitoba has, among other things, 3-5% of P / V, sorbitol; and about 1.8-2.2% of P / V, or an acceptable salt of this drug; (d) about 0.01-0.10% of non ionizing surfactant; and (E) about 1-20 mm of antioxidant; and its pH is between 5.0 and 6.0. This stable formula, the recombined solution, specifically, pembrozuma,It is useful for the treatment of various types of cancer or chronic infections, in which case by intravenous injection or sublethal.Referido a una formulacion de anticuerpo anti-PD 1 humano, que comprende: (a) alrededor de 5 a 200 mg/ml de un anticuerpo anti-PD-1 humano, o un fragmento de union al antigeno del mismo; (b) alrededor de 5 a 20 mM de amortiguador; (c) un estabilizante seleccionado entre: (1) alrededor de 6-8% p/v sacarosa, trehalosa, entre otros; (2) alrededor de 3-5% p/v manitol, sorbitol, entre otros; y alrededor de 1.8-2.2% p/v de glicina, o sal de esta farmaceuticamente aceptable; (d) alrededor de 0.01% a 0.10% de tensioactivo no ionico; y (e) alrededor de 1 a 20 mM de antioxidante; y en donde su pH esta entre 5.0 y 6.0. Esta formulacion estable, de solucion reconstituida, especificamente pembrolizumab, es util para el tratamiento de diversos tipos de cancer o infecciones cronicas, en donde su administracion es por via intravenosa o subcutanea.
来源网站:
中国工程科技知识中心
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