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Last Updated: April 19, 2024

Claims for Patent: 5,612,315

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Summary for Patent: 5,612,315

Title:	Pharmaceutical growth hormone formulations
Abstract:	Parenteral pharmaceutical formulations of human growth hormone, which are stabilized against aggregation, comprising biosynthetic human growth hormone, glycine, and mannitol. Methods of reducing aggregation of human growth hormone in parenteral formulations are also provided.
Inventor(s):	Pikal; Michael J. (Greenwood, IN), Roy; Michael L. (Indianapolis, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	07/909,264
Patent Claims:	1. A parenteral pharmaceutical formulation of human growth hormone which is stabilized against aggregation consisting essentially of biosynthetic human growth hormone in admixture with aggregation stabilizing amounts of glycine and mannitol, wherein said human growth hormone, glycine, and mannitol are present in a weight ratio of about 1:1:3 to about 1:1:5, respectively. 2. The formulation of claim 1 wherein said human growth hormone, glycine and mannitol are present in a weight ratio of 1:1:5, respectively. 3. The formulation of claim 2 as a lyophilized powder. 4. The formulation of claim 3 additionally containing a pharmaceutically acceptable vehicle. 5. The formulation of claim 1 is a lyophilized powder. 6. A method of reducing aggregation of human growth hormone in a parenteral formulation which comprises preparing a parenteral pharmaceutical formulation of human growth hormone which is stabilized against aggregation consisting essentially of biosynthetic human growth hormone in admixture with aggregation stabilizing amounts of glycine and mannitol, wherein said biosynthetic human growth hormone, glycine, and mannitol are present in a weight ratio of about 1:1:3 to about 1:1:5, respectively. 7. The method of claim 6 wherein said human growth hormone, glycine and mannitol are present in a weight ratio of 1:1:5, respectively. 8. The method of claim 7 wherein the parenteral formulation is a lyophilized powder. 9. The method of claim 8 wherein the parenteral formulation additionally contains a pharmaceutically acceptable vehicle. 10. The method of claim 6 wherein the parenteral formulation is a lyophilized powder.

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