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Insulin premix formulation and product, methods of preparing same, and methods of using same
专利权人:
Baxter International, Inc.;Baxter Healthcare SA
发明人:
Joseph Chung Tak Wong,Sarah Elizabeth Lee
申请号:
US16681392
公开号:
US10799564B1
申请日:
2019.11.12
申请国别(地区):
US
年份:
2020
代理人:
摘要:
A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.
来源网站:
中国工程科技知识中心
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http://www.ckcest.cn/home/

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