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METHODS FOR PRODUCING HIGH CONCENTRATION LYOPHILIZED PHARMACEUTICAL FORMULATIONS
专利权人:
发明人:
Akhilesh Bhambhani,Brian K. Meyer,Jeffrey T. Blue
申请号:
US15061449
公开号:
US20160375133A1
申请日:
2016.03.04
申请国别(地区):
US
年份:
2016
代理人:
摘要:
The present invention relates to methods of producing lyophilized pharmaceutical compositions comprising a high concentration of therapeutic protein or antibody prior to lyophilization, wherein the lyophilized formulation can be reconstituted with a diluent in about 15 minutes or less. The invention also relates to the high concentration lyophilized formulations produced by the methods described herein. The lyophilized formulations produced by the methods of the invention are stable and are suitable for veterinary and human medical use and are suitable for modes of administration including oral, pulmonary and parenteral, such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. Also provided by the invention are high concentration pharmaceutical compositions that have long term stability and can be reconstituted, following lyophilization, in a short period of time, preferably 15 minutes or less.
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中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/
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