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Claims for Patent: 5,747,642

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Claims for Patent: 5,747,642

Title: Monomeric insulin analog formulations
Abstract:The present invention discloses various parenteral pharmaceutical formulations, which comprise: a monomeric insulin analog, zinc, protamine, and phenolic derivative. The analog formulations provide a prolonged duration of action. A process for preparing insulin analog-protamine formulations is also described.
Inventor(s): De Felippis; Michael R. (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:08/458,151
Patent Claims: 1. Insulin analog-protamine crystals consisting essentially of: human insulin wherein Pro at position B28 is substituted with Lys, Leu, Val or Ala, and Lys at position B29 is Lys or Pro, des(B28-B30)-human insulin, or des(B27)-human insulin; protamine; zinc; and a phenolic derivative.

2. Crystals of claim 1, which is Lys.sup.B28 Pro.sup.B29 -human insulin, about 0.27 to about 0.32 mg protamine/100 IU of insulin analog, about 0.35 to about 0.9% zinc by weight, and a phenolic derivative.
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