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Claims for Patent: 7,612,176

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Claims for Patent: 7,612,176

Title:Polymer-based sustained release device
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Inventor(s): Wright; Steven G. (Madeira, OH), Christensen; Troy (Mason, OH), Yeoh; Thean (Foxboro, MA), Rickey; Michael E. (Loveland, OH), Hotz; Joyce M. (Cincinnati, OH), Kumar; Rajesh (Marlborough, MA), Costantino; Henry R. (Woodinville, WA)
Assignee: Alkermes, Inc. (Cambridge, MA)
Application Number:11/826,535
Patent Claims: 1. A composition for sustained release of a polypeptide, consisting essentially of: a biocompatible polymer having the polypeptide dispersed therein so as to be present at about 3% (w/w) to about 5% (w/w) of the weight of the composition, and a sugar dispersed therein so as to be present at about 2% (w/w) of the weight of the composition, wherein the composition is free from additional ingredients that alter the rate of release of the polypeptide from the composition.

2. The sustained release composition of claim 1, wherein the biocompatible polymer is selected from poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, and blends and copolymers thereof.

3. The sustained release composition of claim 2, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

4. The sustained release composition of claim 1, wherein the polypeptide is present at about 5% (w/w) of the weight of the composition.

5. The sustained release composition of claim 3, wherein the polypeptide is present at about 5% (w/w) of the weight of the composition.

6. The sustained release composition of claim 1, wherein the sugar is selected from a monosaccharide, a disaccharide, a sugar alcohol, and combinations thereof.

7. The sustained release composition of claim 6, wherein the sugar is selected from sucrose, mannitol, and a combination thereof.

8. The sustained release composition of claim 7, wherein the sugar is sucrose.

9. The sustained release composition of claim 1, wherein the polypeptide is present at about 5% (w/w) of the weight of the composition, and the sugar is sucrose.

10. The sustained release composition of claim 1, wherein the polypeptide is selected from a glucoregulatory peptide and pharmaceutically acceptable salts thereof.

11. The sustained release composition of claim 10, wherein the glucoregulatory peptide is selected from glucagon, glucagon-like peptides, exendins, agonists of glucagon-like peptides, vasoactive intestinal peptide, insulin, and growth hormone.

12. The sustained release composition of claim 11, wherein the glucoregulatory peptide is selected from GLP-1, GLP-2, exendin-3, exendin-4, and combinations thereof.

13. The sustained release composition of claim 12, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

14. The sustained release composition of claim 12, wherein the sugar is sucrose.

15. The sustained release composition of claim 12, wherein the glucoregulatory peptide is selected from exendin-3 and exendin-4.

16. A method of treating a patient having Type 2 diabetes, the method comprising: administering a therapeutically effective amount of a sustained release composition consisting essentially of a biocompatible polymer having a glucoregulatory peptide dispersed therein so as to be present at about 3% (w/w) to about 5% (w/w) of the weight of the composition, and a sugar dispersed therein so as to be present at about 2% (w/w) of the weight of the composition, wherein the composition is free from additional ingredients that alter the rate of release of the glucoregulatory peptide from the composition.

17. The method of claim 16, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

18. The method of claim 16, wherein the glucoregulatory peptide is present at about 5% (w/w) of the weight of the composition.

19. The method of claim 16, wherein the sugar is selected from a monosaccharide, a disaccharide, a sugar alcohol, and combinations thereof.

20. The method of claim 16, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1, wherein the glucoregulatory peptide is present at about 5% (w/w) of the weight of the composition, and the sugar is sucrose.

21. The method of claim 20, wherein the sustained release composition is administered by injection.
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