Val (8) GLP-1 composition and method for treating functional dyspepsia and/or irritable bowel syndrome
View Patent ↗A method of treating functional dyspepsia and/or irritable bowel syndrome in mammals in need of treatment is disclosed herein. The method comprises administering to the mammal a formulation by inhalation, wherein the formulation avoids first pass metabolism of the active ingredient. The method comprises administering a formulation by pulmonary inhalation comprising a diketopiperazine and a glucagon-like peptide (GLP-1), analog, ROSE-010.
1. A dry powder pharmaceutical composition comprising Val (8) glucagon-like peptide-1 (GLP-1) and a diketopiperazine or a pharmaceutically acceptable salt, solvate or prodrug thereof.
2. The composition of claim 1 , wherein said diketopiperazine is a diketopiperazine having the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine, wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, fumaryl, malonyl, oxalyl and citraconyl.
3. The composition of claim 1 , wherein said diketopiperazine comprises a diketopiperazine salt.
4. The composition of claim 2 , wherein said diketopiperazine is 2,5-diketo-3,6-di(4-fumaryl-aminobutyl)piperazine.
5. The composition of claim 1 , wherein said Val (8) GLP-1 is an amidated Val (8) GLP-1.
6. A process for forming a dry powder of claim 1 comprising:
removing a solvent from a co-solution of a Val (8) GLP-1 and a particle-forming diketopiperazine, diketopiperazine particles, or a combination thereof.
7. The process of claim 6 , wherein the solvent is removed from said co-solution by lyophilization, filtration, or spray drying.
8. The process of claim 7 , wherein said particles comprising said Val (8) GLP-1 and said diketopiperazine are formed by removing said solvent by spray drying.
9. The process of claim 7 , wherein said particles comprising said Val (8) GLP-1 and said diketopiperazine are formed prior to removing said solvent.
10. The process of claim 6 , wherein said Val (8) GLP-1 is provided in the form of a solution comprising a Val (8) GLP-1 concentration of about 0.001 mg/ml -50 mg/ml.
11. The process of claim 10 , wherein said Val (8) GLP-1 is provided in the form of a solution comprising a Val (8) GLP-1 concentration of about 0.1 mg/ml -10 mg/ml.
12. The process of claim 10 , wherein said Val (8) GLP-1 is provided in the form of a solution comprising a Val (8) GLP-1 concentration of about 0.25 mg/ml.
13. The process of claim 6 , wherein said diketopiperazine is provided in the form of a suspension of diketopiperazine particles.
14. The process of claim 13 , further comprising adding an agent to said suspension, wherein the agent is selected from the group consisting of salts, surfactants, ions, osmolytes, chaotropes and lyotropes, acids, bases, and organic solvents.
15. The process of claim 14 wherein said agent promotes association between said Val (8) GLP-1 and said diketopiperazine particles.
16. The process of claim 15 , wherein said agent is sodium chloride.
17. A method of administering an effective amount of a Val(8) GLP-1 to a subject in need thereof comprising administering a dry powder of claim 1 by pulmonary delivery.
18. The method of claim 17 , wherein said pulmonary delivery is obtained using a dry powder inhalation system.
19. The method of claim 17 , wherein the dry powder inhalation system comprises a cartridge.