Nasal powder formulation for treatment of hypoglycemia

1. A powder composition comprising glucagon (SEQ ID NO: 1), a phospholipid, and ß-cyclodextrin, wherein the ratio of glucagon to phospholipid to ß-cyclodextrin is 1:1:8 by weight.

2. The powder composition of claim 1 , wherein the phospholipid is at least one member selected from the group consisting of dodecylphosphocholine, didecylphosphatidylcholine, lysolauroylphosphatidylcholine, dioctanoylphosphatidylcholine, dilauroylphosphatidylglycerol or mixtures thereof.

3. The powder composition of claim 2 , wherein the phospholipid is dodecylphosphocholine.

4. The powder composition of claim 2 , wherein the phospholipid is didecylphosphatidylcholine.

5. The powder composition of claim 2 , wherein the phospholipid is lysolauroylphosphatidylcholine.

6. The powder composition of claim 2 , wherein the phospholipid is dioctanoylphosphatidylcholine.

7. The powder composition of claim 2 , wherein the phospholipid is dilauroylphosphatidylglycerol.

8. A powder composition consisting of glucagon (SEQ ID NO: 1), dodecylphosphocholine, and ß-cyclodextrin, wherein the ratio of glucagon to dodecylphosphocholine to ß-cyclodextrin is 1:1:8 by weight.

9. The powder composition according to claim 1 , further comprising sodium citrate or citric acid.

10. The powder composition according to claim 9 , wherein the amount of sodium citrate or citric acid is up to 10 percent by weight of the overall weight of the composition.

11. The powder composition according to claim 1 , further comprising water.

12. The powder composition according to claim 11 wherein the water content of the composition is below 5 percent by weight of the overall weight of the composition.

13. A nasal applicator for a powder formulation, said applicator including a powder formulation reservoir, and a powder formulation contained within the reservoir, wherein the powder formulation is a composition in accordance with claim 1 .

14. A method for preparing a powder formulation of claim 1 , wherein at least a portion of the powder is present in a phase characterized by an XRPD mesopeak as determined by x-ray powder diffraction, said method comprising the steps of

a. forming a first solution of the glucagon (SEQ ID NO. 1) and the phospholipid in an aqueous carrier, wherein the phospholipid is present in a concentration greater than or equal to the critical micelle concentration;

b. adding the ß-cyclodextrin to the first mixture to form a second mixture;

c. drying the second mixture to form a solid formulation; and

d. processing the solid formulation to produce a uniform powder, said uniform powder including at least a portion of the powder in a phase characterized by an XRPD mesopeak.

15. A method for preparing a powder formulation of claim 1 , said method comprising the steps of

a. forming a first solution of the glucagon (SEQ ID NO. 1) and the phospholipid in an aqueous carrier, wherein the phospholipid is present in a concentration greater than or equal to the critical micelle concentration;

b. adding the ß-cyclodextrin to the first mixture to form a second mixture;

c. drying the second mixture to form a solid formulation; and

d. processing the solid formulation to produce a uniform powder.

16. The method of claim 14 , wherein the drying of the second mixture is carried out by freeze drying or spray drying the second mixture.

17. The method of claim 15 , wherein the drying of the second mixture is carried out by freeze drying or spray drying the second mixture.

18. A method for treating hypoglycemia in an individual suffering from hypoglycemia comprising administering to the individual a composition in accordance with claim 1 , wherein the composition is administered in a therapeutically effective amount as a powder to the nasal mucosa of the individual.

19. The method of claim 18 , wherein the powder formulation is administered to only one nostril of the individual.