Composition for sustained release of human growth hormone
First Claim
1. A composition for the sustained release of human growth hormone from a polymeric matrix, comprising:
- a) a biocompatible polymer; and
b) particles of metal cation-complexed human growth hormone, wherein said particles are dispersed within the biocompatible polymer.
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Accused Products
Abstract
A composition, and methods of forming and using said composition, for the sustained release of biologically active, stabilized human growth hormone (hGH). The sustained release composition of this invention comprises a polymeric matrix of a biocompatible polymer and particles of biologically active, stabilized hGH, wherein said particles are dispersed within the biocompatible polymer. The method of the invention for producing a composition for the sustained release of biologically active hGH, includes dissolving a biocompatible polymer in a polymer solvent to form a polymer solution, dispersing particles of biologically active, stabilized hGH in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of said hGH particles. The method for using a composition of the invention is a method for providing a therapeutically effective blood level of biologically active, non-aggregated hGH in a subject for a sustained period. In this method, a subject is administered an effective dose of the sustained release composition of the present invention. The method of using the sustained release composition of the present invention comprises providing a therapeutically effective blood level of biologically active, non-aggregated human growth hormone in a subject for a sustained period by administering to the subject a dose of said sustained release composition.
255 Citations
11 Claims
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1. A composition for the sustained release of human growth hormone from a polymeric matrix, comprising:
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a) a biocompatible polymer; and b) particles of metal cation-complexed human growth hormone, wherein said particles are dispersed within the biocompatible polymer. - View Dependent Claims (2, 3, 4, 5, 6, 9)
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7. A composition for the sustained release of human growth hormone from a polymeric matrix, comprising:
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a) poly(lactide-co-glycolide); b) particles of zinc-complexed human growth hormone, with a zinc-to-human growth hormone molar ratio between 4;
1 and 100;
1, wherein said particles are dispersed within the poly(lactide-co-glycolide, and wherein the proportion of human growth hormone in the sustained release composition is between 10 and 30 weight percent; andc) a second metal cation component, wherein the second metal cation component is not complexed to said human growth hormone, and wherein the second metal cation component is dispersed within the polymeric matrix at a concentration of at least about 1% by weight of polymer. - View Dependent Claims (8, 10, 11)
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Specification