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PROCESS FOR MANUFACTURING A PHARMACEUTICAL PREPARATION CONTAINING GLATIRAMER ACETATE
专利权人:
发明人:
申请号:
HK16113726.6
公开号:
HK1225309B
申请日:
2016.12.01
申请国别(地区):
HK
年份:
2018
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 40 mg/ml glatiramer acetate and 40 mg/ml mannitol, wherein the aqueous pharmaceutical solutiona) has a viscosity in the range of 2.0-3.5 cPa orb) 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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