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Process Of Manufacturing A Stable, Ready To Use Infusion Bag For An Oxidation Sensitive Formulation
专利权人:
InnoPharma Licensing LLC
发明人:
Tushar Hingorani,Kumaresh Soppimath,Rekha Nayak,Tushar Malkan,Satish Pejaver,Navneet Puri
申请号:
US14246047
公开号:
US20140303254A1
申请日:
2014.04.05
申请国别(地区):
US
年份:
2014
代理人:
摘要:
A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient is provided. The oxidation susceptible active pharmaceutical ingredient is mixed with excipients and deoxygenated water to prepare a non-sterile drug solution. The non-sterile drug solution is filled into a moist heat sterilizable flexible infusion bag. The flexible infusion bag with the non-sterile drug solution is terminally moist heat sterilized at a preset air overpressure between about 0.2 bar to about 1.2 bar to obtain a parenteral drug product. The highest degradation product in the parenteral drug product is less than 0.5% by weight of a labeled amount of the oxidation susceptible active pharmaceutical ingredient in the parenteral drug product.
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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