含有因子VIII的穩定藥物組合物

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专利权人:

IPSEN PHARMA S.A.S.

发明人:

WHITE, MARY,WEBB, PAUL

申请号：

HK13110894.1

公开号：

HK1183446B

申请日:

2013.09.24

申请国别(地区):

HK

年份:

2016

代理人:

摘要：

A method for preparing a lyophilisate, comprising: (a) preparing of a solution comprising； factor VIII in a concentration ranging from 50 to 10,000 international units/ml, a surfactant in a concentration ranging from above critical micellar concentration to 1% v/v, calcium chloride in a concentration ranging from 0.5 to 10 mM, sucrose in a concentration ranging from 5 to 50 mM, sodium chloride in a concentration ranging from 0.15 to 0.5 M, trisodium citrate in a concentration ranging from 1 to 50 mM, and a buffer in a concentration ranging from 1 to 50 mM, and (b) lyophilising the solution. The invention also relates to the lyophilisate obtainable by said method and a liquid pharmaceutical composition prepared therefrom.

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