DIX, DANIEL B.,GRAHAM, KENNETH S.,KAMEN, DOUGLAS E.,WALSH, SCOTT M.
申请号：
PE0009702012
公开号：
PE16872012A1
申请日:
2011.01.07
申请国别(地区):
PE
年份:
2012
代理人:
摘要：
Refers to a Pharmaceutical formulation comprising: (i) a Human Antibody that binds to the Receptor of Human interleukin-6 (HIL 6R) at a concentration of approximately 5 mg \/ ml.(ii) histidine in a concentration between 5 to 50 mm, and (iii) a carbohydrate such as Glucose, mannitol, sucrose, Lactose and Trehalose at a concentration of approximately 1% to 20%, also comprises a nonionic Surfactant and arginine.Said Antibody comprises amino acid sequences of the variable region of heavy chain and light chain selected from the group consisting of: (i) SEQ ID no: 2 \/ 10, (ii) SEQ ID no: 18 \/ 26, among others, and complementarity determining regions of the heavy and light chain (hcdr1 - hcdr2 - hcdr3 LCdr \/ 1 - lcdr2 - lcdr3) are the amino acid sequences of SEQ ID no: (i): 4 - 6 - 8 \/ SEQ ID no: 12 - 14 - 16(ii) SEQ ID no: 20 - 22 - 24 \/ SEQ ID no: 28 - 30 - 32, among others. This formulation is useful for the treatment of rheumatoid arthritis, psoriasis, vasculitis, pancreatitis, multiple sclerosisSE REFIERE A UNA FORMULACION FARMACEUTICA QUE COMPRENDE: (I) UN ANTICUERPO HUMANO QUE SE UNE AL RECEPTOR DE INTERLEUQUINA-6 HUMANA (hIL-6R) EN UNA CONCENTRACION DE APROXIMADAMENTE 5 A 200mg/ml. (II) HISTIDINA EN UNA CONCENTRACION ENTRE 5 A 50 mM, Y (III) UN CARBOHIDRATO TAL COMO SACAROSA, GLUCOSA, MANITOL, LACTOSA Y TREHALOSA EN UNA CONCENTRACION DE APROXIMADAMENTE 1% A 20%, ADEMAS COMPRENDE UN TENSIOACTIVO NO IONICO Y ARGININA. DICHO ANTICUERPO COMPRENDE SECUENCIAS DE AMINOACIDOS DE LA REGION VARIABLE DE CADENA PESADA Y CADENA LIGERA SELECCIONADAS DEL GRUPO QUE CONSISTE EN: (i) SEQ ID NO:2/10, (ii) SEQ ID NO:18/26, ENTRE OTROS, Y REGIONES DETERMINANTES DE COMPLEMENTARIEDAD DE CADENA PESADA Y LIGERA (HCDR1-HCDR2-HCDR3/LCDR1-LCDR2-LCDR3) TIENEN LAS SECUENCIAS DE AMINOACIDOS DE: (i) SEQ ID NO:4-6-8/SEQ ID NO:12-14-16, (ii) SEQ ID NO:20-22-24/SEQ ID NO: 28-30-32, ENTRE OTROS.. DICHA FORMULACION ES UTIL PARA EL TRATAMIENTO DE ARTRITIS REUMATOIDE, PANCREATITIS, PSORIASIS, VASCU
