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Claims for Patent: 7,563,871

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Claims for Patent: 7,563,871

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), Fineman; Mark (San Diego, CA), Smith; Christine (San Diego, CA), Ong; John (San Diego, CA), Lokensgard; David (San Diego, CA), Costantino; Henry R. (Woodinville, WA)
Assignee: Alkermes, Inc. (Cambridge, MA) Amylin Pharmaceuticals, Inc. (San Diego, CA)
Application Number:11/521,091
Patent Claims: 1. A composition for sustained release of biologically active polypeptide over a period of release consisting essentially of a biocompatible polymer, a biologically active polypeptide and a sugar, wherein a total pore volume of the composition is about 0.1 mL/g or less as determined using mercury intrusion porosimetry to provide a release profile having a ratio of maximum serum concentration of the biologically active polypeptide during the period of release (C.sub.max) to average serum concentration of the biologically active polypeptide during the period of release (C.sub.ave) of about 3 or less.

2. The sustained release composition of claim 1, wherein the polypeptide is selected from glucagon, glucagon-like peptides, exendins, agonists of glucagon like peptides, vasoactive intestinal peptide, immunoglobulins, antibodies, cytokines, interleukins, macrophage activating factors, interferons, erythropoietin, tumor necrosis factor, colony stimulating factors, insulin, enzymes, tumor suppressors, blood proteins, follicle stimulating hormone, growth hormone, adrenocorticotropic hormone, and luteinizing hormone releasing hormone, NGF, EGF, gastrin, GRH, defensin, enkephalins, and muteins, analogs, deletion and substitution variants and pharmaceutically acceptable salts thereof.

3. The sustained release composition of claim 2, wherein the biologically active polypeptide is a glucoregulatory peptide.

4. The sustained release composition of claim 3, wherein the glucoregulatory peptide is selected from GLP- 1, GLP-2, exendin-3, exendin-4 or a combination thereof.

5. The sustained release composition of claim 4, wherein the polypeptide is present from about 0.1% w/w to about 10% w/w of the total weight of the sustained release composition.

6. The sustained release composition of claim 5, wherein the polypeptide is present from about 0.5% w/w to about 5% w/w of the total weight of the sustained release composition.

7. The sustained release composition of claim 6, wherein the sugar is present from about 0.01% w/w to about 10% w/w of the total weight of the sustained release composition.

8. The sustained release composition of claim 7, wherein the sugar is present from about 0.1% w/w to about 5% w/w of the total weight of the sustained release composition.

9. The sustained release composition of claim 8, wherein the sugar is selected from a monosaccharide, a disaccharide, a sugar alcohol or a combination thereof.

10. The sustained release composition of claim 9, wherein the sugar is selected from sucrose, mannitol and combinations thereof.

11. The sustained release composition of claim 8, wherein the biocompatible polymer is selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalate)s, biodegradable polyurethanes, blends thereof and copolymers thereof.

12. The sustained release composition of claim 11, wherein said polymer comprises poly(lactide-co-glycolide).

13. The sustained release composition of claim 12 wherein said polymer is a 50:50 poly(lactide-co-glycolide).

14. The sustained release composition of claim 13 wherein said polymer has an inherent viscosity of between about 0.3 and 0.5 dL/g.

15. A composition for sustained release of biologically active polypeptide over a period of release consisting of a biocompatible polymer, exendin-4 at about 5% w/w or more and sucrose at about 2% w/w or more of the weight of the composition, 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, wherein a total pore volume of the composition is about 0.1 mL/g or less as determined using mercury intrusion porosimetry to provide a release profile having a ratio of maximum serum concentration of the exendin-4 during the period of release (C.sub.max) to average serum concentration of the exendin-4 during the period of release (C.sub.ave) of about 3 or less.

16. A pharmaceutically acceptable composition for sustained release of biologically active polypeptide over a period of release consisting essentially of a purified 50:50 DL PLG 4A polymer having dispersed therein exendin-4 at about 5% (w/w) or more and sucrose at about 2% (w/w) or more of the weight of the composition, wherein said composition has an absence of ammonium sulfate, wherein a total pore volume of the composition is about 0.1 mL/g or less as determined using mercury intrusion porosimetry to provide a release profile having a ratio of maximum serum concentration of the exendin-4 during the period of release (C.sub.max) to average serum concentration of the exendin-4 during the period of release (C.sub.ave) of about 3 or less and said composition is suitable for administration to a human for the treatment of diabetes mellitus.

17. The sustained release composition of claim 1, wherein the period of release is about one week.

18. The composition of claim 15, wherein the period of release is about one week.

19. The pharmaceutically acceptable composition of claim 16, wherein the period of release is about one week.

20. The sustained release composition of claim 17, wherein the biologically active polypeptide is exendin-4.
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