Eli Lilly and Company

Michael R De Felippis

Bruce H Frank

Henry Acken Havel

James H Anderson, Jr

The present invention discloses various parenteral pharmaceutical formulations having a protracted effect, which comprise: a sterile aqueous suspension of about 20 U/mL to about 500 U/mL insulin analog, about 5 mg/mL to about 10 mg/mL sodium chloride, about 0.2 to about 2.0 mg/mL physiologically acceptable buffer, a zinc ion content of about 0.07 mg/mL to about 0.1 mg/mL, and a physiologically acceptable preservative at a pH of about 6.5 to about 7.8; such that less than 5% of the analog present in the suspension is in the dissolved state.

Monomeric insulin analog formulations

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.

The present invention discloses various parenteral pharmaceutical formulations, which comprise a mixture of a monomeric insulin analog and insulin-NPH. The analog formulations provide a rapid onset and a prolonged duration of action.

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Indianapolis, IN, United States of America

Michael R De Felippis