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Details for Patent: 7,906,146

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Details for Patent: 7,906,146

Title:Lyophilized formulations of exendins and exendin agonist analogs
Abstract: Novel formulations containing exendins, exendin agonists and/or exendin analogs are provided.
Inventor(s): Kolterman; Orville G. (San Diego, CA), Young; Andrew A. (Rancho Santa Fe, CA), L'Italien; James J. (San Diego, CA)
Assignee: Amylin Pharmaceuticals, Inc. (San Diego, CA)
Filing Date:Feb 20, 2009
Application Number:12/389,509
Claims:1. A lyophilized formulation comprising about 0.005% (w/v) to about 0.4% (w/v) exendin-4 and about 1.0% (w/v) to about 10% (w/v) mannitol.

2. A lyophilized formulation comprising about 0.005% (w/v) to about 0.4% (w/v) of exendin-4 or an exendin agonist analog thereof and about 1.0% (w/v) to about 10% (w/v) of one or more compounds selected from the group consisting of mannose, ribose, trehalose, maltose, glycerol, inositol, glucose, lactose, galactose, arabinose, sorbitol, mannitol, glycerol, xylitol, a polypropylene/ethylene glycol copolymer, and a polyethylene glycol.

3. The lyophilized formulation of claim 2, wherein the formulation comprises exendin-4.

4. The lyophilized formulation of claim 2, wherein the exendin or the exendin agonist analog is present in an amount of about 0.005% (w/v) to about 0.02% (w/v).

5. The lyophilized formulation of claim 2, wherein the formulation comprises exendin-4.

6. A lyophilized formulation comprising about 0.005% (w/v) to about 0.4% (w/v) of exendin-4 or an exendin agonist analog thereof and about 1.0% (w/v) to about 10% (w/v) of a bulking agent.

7. The lyophilized formulation of claim 6, wherein the bulking agent is a carbohydrate, a polyhydric alcohol, or a combination thereof.

8. The lyophilized formulation of claim 7, wherein the carbohydrate is mannose, ribose, trehalose, maltose, glycerol, inositol, glucose, lactose, galactose, or arabinose.

9. The lyophilized formulation of claim 7, wherein the polyhydric alcohol is sorbitol, mannitol, glycerol, xylitol, a polypropylene/ethylene glycol copolymer, or a polyethylene glycol.

10. The lyophilized formulation of claim 6, wherein the bulking agent is mannitol.

11. The lyophilized formulation of claim 6, further comprising about 0.1% (w/v) to about 1.0% (w/v) of a surfactant.

12. The lyophilized formulation of claim 6, further comprising about 0.02% (w/v) to about 0.5% (w/v) of a buffer.

13. The lyophilized formulation of claim 12, wherein the buffer is an acetate buffer, a phosphate buffer, a citrate buffer, a glutamate buffer, or a combination of two or more thereof.

14. The lyophilized formulation of claim 6, further comprising about 0.005% (w/v) to about 1.0% (w/v) of an anti-microbial preservative.

15. The lyophilized formulation of claim 14, wherein the anti-microbial preservative is m-cresol, benzyl alcohol, methyl paraben, ethyl paraben, propyl paraben, butyl paraben, or phenol.

16. The lyophilized formulation of claim 6, comprising about 0.005% (w/v) to about 0.02% (w/v) of the exendin or the exendin agonist analog.

17. The lyophilized formulation of claim 6, comprising about 0.005% (w/v) to about 0.05% (w/v) of the exendin or the exendin agonist analog.

18. The lyophilized formulation of claim 6, wherein the lyophilized formulation is a unit dosage formulation or a multi-unit dosage formulation.

19. The lyophilized formulation of claim 6, wherein the exendin or the exendin agonist analog comprises the amino acid sequence of any one of SEQ ID NOs: 4-239.

20. The lyophilized formulation of claim 6, wherein the formulation comprises exendin-4.
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