Aqueous glycerol formulations of somatotropin
AssigneeMonsanto Technology LLC
InventorDaniel Nicholas Heintz
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Abstract
Aqueous somatotropin compositions are presented that contain less than about 10% of a biologically active somatotropin, water, and glycerol in an amount effective and at a pH effective to maintain the somatotropin substantially completely stable. The somatotropins in such compositions preferably retain their physical and chemical stability for at least 2 years. The somatotropin compositions also preferably have anti-microbial activity, such that, after they have been sterile-filtered, no additional anti-microbial agent is necessary to maintain the sterility of the composition.
Claims16
An injectable aqueous glycerol somatotropin composition comprising:
- a biologically active somatotropin in a concentration less than 6% by weight of the composition, a surfactant, water and glycerol in an amount effective and at a pH effective to maintain the somatotropin substantially completely stable;
- wherein the ratio of glycerol to water, by volume, is about 1:1 to 4:1.
An injectable aqueous glycerol somatotropin composition suitable for parenteral administration comprising:
- a biologically active somatotropin in a concentration of about 0.01% to about 3.0% by weight of the composition, a surfactant, water and glycerol in an amount effective and at a pH effective to maintain the somatotropin substantially completely stable;
- wherein the ratio of glycerol to water, by volume, is about 1:1 to 4:1.
Dependencies are inferred from the claim text.