АРМСТРОНГ Николас Дж. (US),БАУЭН Маюми Н. (US),МАА Юй-Фань (US)
申请号：
RU2014151359
公开号：
RU2014151359A
申请日:
2013.05.17
申请国别(地区):
RU
年份:
2016
代理人:
摘要：
1. A suspension composition containing a spray dried monoclonal antibody at a concentration of about 200 mg / ml or more, suspended in a non-aqueous suspension vehicle, the viscosity of the suspension vehicle being less than about 20 centipoise. The composition of claim 1, wherein the viscosity of the filler for the suspension is less than about 10 centipoise. The composition according to claim 2, wherein the viscosity of the filler for the suspension is less than about 5 centipoise. A composition according to any one of the preceding claims, wherein the sliding friction force of the composition upon injection is about 20 Newtons or less. A composition according to claim 4, wherein the sliding friction force of the composition upon injection is about 15 Newtons or less. A composition according to claim 1, wherein the average particle size in the composition is from about 2 microns to about 30 microns. The composition of claim 6, wherein the average particle size of the composition is from about 2 microns to about 10 microns. A composition according to claim 1, wherein the concentration of the antibody in the composition is from about 200 mg / ml to about 500 mg / ml. The composition of claim 8, wherein the concentration of the antibody in the composition is from about 200 mg / ml to about 350 mg / ml. The composition according to claim 1, further comprising a saccharide. 11. The composition of claim 10, wherein the saccharide is trehalose or sucrose. The composition of claim 10 or 11, wherein the molar ratio of saccharide: monoclonal antibody is from about 50 to about 400: 1.13. The composition of claim 12, wherein the molar ratio of saccharide: monoclonal antibody is from about 100 to about 250: 1.14. The composition of claim 1, further comprising a surfactant. The composition according to p. 14, in which the surface-active substance is polysorbate 20 or polysorbate 80.16. The composition according to claim 1, which is suitable for subcutaneous injection1. Суспензи
