COMPOSITIONS AND METHODS FOR ENHANCED MUCOSAL DELIVERY OF PYY PEPTIDE

• US 20070129299A1
• Filed: 08/25/2006
• Published: 06/07/2007
• Est. Priority Date: 12/17/2002
• Status: Abandoned Application

• Current Assignee: Nastech Pharmaceutical Company Inc. (Adhera Therapeutics, Inc.)
• Original Assignee: Nastech Pharmaceutical Company Inc. (Adhera Therapeutics, Inc.)
• Inventors: Quay, Steven, Brandt, Gordon, MacEvilly, Conor, Kleppe, Mary
• Application Number:
  US11/467,509
• Publication Number:
  US 20070129299A1
• Time in Patent Office: Days
• US Class Current: 514/5.200
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/724 Cyclodextrins
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/2271 Neuropeptide Y
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/40 Cyclodextrins; Derivatives thereof
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Pharmaceutical compositions are described comprising PYY(3-36) (SEQ ID NO: 2), a solubilizing agent, a lipid, a polyol.

Claims

1. A peptide YY (PYY) composition comprised of PYY(3-36) (SEQ ID NO:

2), a solubilizing agent, a lipid, a polyol selected from the group consisting of sucrose, mannitol, sorbitol, lactose, L-arabinose, D-erythrose, D-ribose, D-xylose, D-mannose, trehalose, D-galactose, lactulose, cellobiose, gentibiose, glycerin and polyethylene glycol.

2. The PYY composition of claim 1 wherein the solubilizing agent is selected from the group consisting of a cyclodextrin, hydroxypropyl-β

-cyclodextrin, sulfobutylether-β

-cyclodextrin and methyl-β

-cyclodextrin.

3. The PYY composition of claim 2 wherein the solubilizing agent is a methyl-β

-cyclodextrin.

4. The PYY composition of claim 1 wherein the lipid is a phospholipid.

5. The PYY composition of claim 4 wherein the phospholipid is a phosphatidylcholine.

6. The PYY composition of claim 5 wherein the phosphatidylcholine is L-α

-phosphatidylcholine didecanoyl (DDPC).

7. The PYY composition of claim 1 wherein the polyol is sorbitol.

8. The PYY composition of claim 1 wherein the composition is further comprised of a chelating agent.

9. The PYY composition of claim 8 wherein the chelating agent is ethylene diamine tetraacetic acid (EDTA) or ethylene glycol tetraacetic acid (EGTA).

10. The PYY composition of claim 9 wherein the chelating agent is EDTA.

11. The PYY composition of claim 1 wherein the composition is an aqueous PYY composition further comprised of water.

12. The PYY composition of claim 11 wherein the aqueous PYY composition has a pH of about of about 3 to about 6.

13. The PYY composition of claim 12 wherein the pH of the aqueous PYY composition is 5.0±

0.5.

14. A PYY composition comprised of a solubilizing agent, a phosphatidylcholine, a polyol, and PYY(3-36) (SEQ ID NO:

2).

15. The PYY composition of claim 14 wherein the polyol is selected from the group consisting of sucrose, mannitol, sorbitol, lactose, L-arabinose, D-erythrose, D-ribose, D-xylose, D-mannose, trehalose, D-galactose, lactulose, cellobiose, gentibiose, glycerin and polyethylene glycol.

16. The PYY composition of claim 15 wherein the polyol is sorbitol.

17. The PYY composition of claim 14 wherein the composition further comprises a chelating agent.

18. The PYY composition of claim 17 wherein the chelating agent is ethylene diamine tetraacetic acid (EDTA) or ethylene glycol tetraacetic acid (EGTA).

19. The PYY composition of claim 18 wherein the chelating agent is EDTA.

20. The PYY composition of claim 14 wherein the solubilizing agent is selected from the group consisting of a cyclodextrin, hydroxypropyl-β

-cyclodextrin, sulfobutylether-β

-cyclodextrin and methyl-β

-cyclodextrin.

21. The PYY composition of claim 20 wherein the solubilizing agent is a methyl-β

-cyclodextrin.

22. The PYY composition of claim 14 wherein the phosphatidylcholine is L-α

-phosphatidylcholine didecanoyl (DDPC).

23. The PYY composition of claim 14 wherein the composition is an aqueous PYY composition further comprised of water.

24. The PYY composition of claim 23 wherein the aqueous PYY composition has a pH of about 3 to about 6.

25. The PYY composition of claim 25 wherein the pH of the aqueous PYY composition is 5.0±

0.5.

26. A peptide YY (PYY) composition comprised of PYY(3-36) (SEQ ID NO:

2), a polyol, EDTA, and a surfactant selected from the group consisting of Tween 20, Tween 80, cetyl alcohol, and lanolin alcohol lipid.

27. The PYY composition of claim 26, where in polyol is selected from the group consisting of sucrose, mannitol, sorbitol, lactose, L-arabinose, D-erythrose, D-ribose, D-xylose, D-mannose, trehalose, D-galactose, lactulose, cellobiose, gentibiose, glycerin and polyethylene glycol.

28. The PYY composition of claim 26 wherein the aqueous PYY composition has a pH of about 3 to about 6.

29. The PYY composition of claim 26 wherein the pH of the aqueous PYY composition is 5.0±

0.5.