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Process for manufacturing glatiramer acetate product
专利权人:
Teva Pharmaceutical Industries Ltd
发明人:
COHEN, Rakefet,HABBAH, Sasson,SAFADI, Muhammad
申请号:
AU2016273881
公开号:
AU2016273881A1
申请日:
2016.12.14
申请国别(地区):
AU
年份:
2017
代理人:
摘要:
#$%^&*AU2016273881A120170105.pdf#####Abstract 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 OC up to 17.50C 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.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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