Baxter International Inc.
Insulin premix formulation and product, methods of preparing same, and methods of using same

Abstract:

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.degree. C. to 5.degree. C. for 24 months followed by additional 30 days at room temperatures of 23.degree. C. to 27.degree. C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.