COHEN Rakefet,COHEN Rakefet,HABBAH Sasson,HABBAH Sasson,SAFADI Muhammad,SAFADI Muhammad
申请号：
SI201530058
公开号：
SI3050556T1
申请日:
2015.09.24
申请国别(地区):
SI
年份:
2017
代理人:
摘要：
The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0°C up to 17.5°C to produce a filtrate and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40mg/ml glatiramer acetate and 40mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.
