Eli Lilly and Company

Michael Rosario DeFelippis

Michael Allen Dobbins

Bruce H Frank

Shun Li

Dawn Marie Rebhun

Kingman Ng

Richard Dennis DiMarchi

Virender Kumar Sarin

Henry Acken Havel

Joseph Vincent Rinella, Jr

Michael Trautmann

Kenneth Francis Mace

Alby David Sharknas

Alex Mark Prokai

The present invention encompasses pre-mixed formulations comprising a GLP-1 polypeptide and a basal insulin.

Pre-mixes of GLP-1 and basal insulin

The present invention encompasses pharmaceutical formulations comprising a biphasic mixture which comprises a glucagon like peptide (GLP-1) compound in a solid phase and an insulin in a solution phase.

Biphasic mixtures of GLP-1 and insulin

The present invention encompasses compositions wherein a GLP-1 compound is complexed with a basic polypeptide. The compositions provide a prolonged duration of action and can be administered by the pulmonary route.

GLP-1 formulations with protracted time action

The present invention provides means to improve the chemical stability of aqueous, parenteral pharmaceutical compositions comprising a polypeptide and glycerin. Reactive aldehydes are identified in commercial glycerins, and means for reducing such are provided. Convenient means are provided to assay for reactive aldehydes in glycerin, and a strong linear correlation between the level of reactive aldehydes in glycerin and chemical stability of compositions comprising a polypeptide and glycerin is demonstrated. The invention includes aqueous compositions comprising a polypeptide and glycerin having improved chemical stability compared to compositions previously known.

Polypeptide compositions with improved stability

The present invention provides a monomeric insulin analog formulation stabilized against aggregation in which the buffering agent is either TRIS or arginine. The stable formulations of the present invention are useful for treating diabetes, and are particularly advantageous in treatment regimes requiring lengthy chemical and physical stability, such as, in continuous infusion systems.

Stable insulin formulations

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Carmel, IN, United States of America

Michael Rosario DeFelippis