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Claims for Patent: 7,456,254

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Claims for Patent: 7,456,254

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), Christenson; Troy (Mason, OH), Yeah; Thean Y. (Foxboro, MA), Rickey; Michael E. (Morrow, OH), Hotz; Joyce M. (Cincinnati, OH), Kumar; Rajesh (Marlborough, MA), Costantino; Henry R. (Woodinville, WA)
Assignee: Alkermes, Inc. (Cambridge, MA)
Application Number:11/104,877
Patent Claims: 1. A composition for sustained-release of exendin-4, consisting essentially of: a biocompatible polymer having dispersed therein about 3%-5% (w/w) exendin-4 and about 2% (w/w) sucrose, wherein the composition is free from additional ingredients that alter the rate of release of the exendin-4 from the composition.

2. A composition for sustained-release of a polypeptide, consisting of: a biocompatible polymer having dispersed therein about 5% (w/w) exendin-4 and about 2% (w/w) sucrose.

3. A composition for sustained-release of a polypeptide, consisting of: a biocompatible polymer having dispersed therein about 3%-5% (w/w) exendin-4 and about 2% (w/w) sucrose.

4. The 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.

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

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

7. The composition of claim 1, wherein the exendin-4 is present at about 5% (w/w) and the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

8. A composition for sustained-release of exendin-4, consisting essentially of: a biocompatible polymer having dispersed therein about 5% (w/w) exendin-4 and about 2% (w/w) sucrose, wherein the composition is free from additional ingredients that alter the rate of release of the exendin-4 from the composition.

9. The composition of claim 8, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1 and a molecular weight in the range of from about 45 to about 64 kDa.

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

11. The composition of claim 1, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1 and a molecular weight in the range of from about 45 to about 64 kDa.

12. The composition of claim 2, 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.

13. The composition of claim 2, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1 and a molecular weight in the range of from about 45 to about 64 kDa.

14. The composition of claim 3, 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.

15. The composition of claim 3, wherein the exendin-4 is present at about 5% (w/w) and the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

16. The composition of claim 3, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1 and a molecular weight in the range of from about 45 to about 64 kDa.

17. The composition of claim 8, 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.

18. The composition of claim 8, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

19. A method of treating a patient having Type 2 diabetes comprising: administering a therapeutically effective amount of a sustained-release composition consisting essentially of a biocompatible polymer having dispersed therein about 3%-5% (w/w) exendin-4 and about 2% (w/w) sucrose, wherein the sustained-release composition is free from additional ingredients that alter the rate of release of the exendin-4 from the sustained-release composition.

20. The method of claim 19, wherein the exendin-4 is present at about 5% (w/w) and the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

21. The method of claim 19, wherein the sustained-release composition is administered by injection.

22. The method of claim 19, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

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

24. A method of treating a patient having Type 2 diabetes comprising: administering a therapeutically effective amount of a sustained-release composition consisting of a biocompatible polymer having dispersed therein about 5% (w/w) exendin-4 and about 2% (w/w) sucrose.

25. The method of claim 24, wherein the biocompatible polymer is poly(lactide-co-glycolide) with a lactide:glycolide ratio of about 1:1.

26. The method of claim 24, wherein the sustained-release composition is administered by injection.

27. The method of claim 25, wherein the sustained-release composition is administered by injection.
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