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Last Updated: March 29, 2024

Claims for Patent: 8,084,493


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Summary for Patent: 8,084,493
Title:Pharmaceutical composition of peptide drug and enzyme-inhibition compounds
Abstract: The invention relates to a method of co-administering a peptide or protein drug with an enzyme-resistant PGA-complexone compound orally so to mitigate enzyme attack in the gastrointestinal tract of an animal subject.
Inventor(s): Sung; Hsing-Wen (Hsinchu, TW), Sonaje; Kiran (Hsinchu, TW), Tu; Hosheng (Newport Beach, CA)
Assignee: GP Medical, Inc. (Newport Beach, CA) National Tsing Hua University (Hsinchu, TW)
Application Number:13/068,535
Patent Claims:1. A method of delivering a drug with enhanced enzymatic inhibition property to an animal subject, the method comprising co-administering a PGA-complexone conjugate and a composition of nanoparticles that are loaded with said drug to said animal subject orally, wherein the nanoparticles consist of positively charged chitosan, a negatively charged substrate, optionally a zero-charge compound, and said drug.

2. The method of claim 1, wherein the PGA-complexone conjugate is PGA-DTPA.

3. The method of claim 1, wherein said PGA-complexone conjugate and said nanoparticles are formulated into a tablet or pill configuration.

4. The method of claim 3, wherein said tablet or pill is treated with an enteric coating polymer.

5. The method of claim 1, wherein said PGA-complexone conjugate and said nanoparticles are encapsulated in a capsule.

6. The method of claim 5, wherein said capsule further comprises a pharmaceutically acceptable carrier, diluent, or excipient, a solubilizer, bubbling agent, or emulsifier.

7. The method of claim 5, wherein said capsule is treated with an enteric coating polymer.

8. The method of claim 5, wherein said capsule further comprises at least one permeation enhancer.

9. The method of claim 8, wherein said permeation enhancer is selected from the group consisting of Ca.sup.2+ chelators, bile salts, surfactants, medium-chain fatty acids, phosphate esters, and chitosan.

10. The method of claim 9, wherein said chitosan is selected from the group consisting of N-trimethyl chitosan (TMC), low MW-chitosan, EDTA-chitosan, pegylated chitosan (PEG-chitosan), mono-N-carboxymethyl chitosan (MCC), chitosan derivatives, and combinations thereof.

11. The method of claim 1, wherein said drug is a pegylated drug.

12. The method of claim 1, wherein said drug is covalently attached with polyethylene glycol polymer chains.

13. The method of claim 1, wherein said drug is insulin, an insulin analog, or osteocalcin.

14. The method of claim 1, wherein said drug is an insulin sensitizer.

15. The method of claim 1, wherein said drug is an insulin secretagogue.

16. The method of claim 1, wherein said drug is GLP-1 or a GLP-1 analog.

17. The method of claim 1, wherein said drug is an inhibitor of dipeptidyl peptidase 4 (DIP-4 inhibitor).

18. The method of claim 1, wherein said drug is exenatide, liraglutide, albiglutide, lixisenatide, or taspoglutide.

19. The method of claim 1, wherein said drug is selected from the group consisting of alpha-glucosidase inhibitors, amylin analog, sodium-glucose co-transporter type 2 (SGLT2) inhibitors, benfluorex, and tolrestat.

20. The method of claim 1, wherein said chitosan is selected from the group consisting of N-trimethyl chitosan (TMC), low MW-chitosan, EDTA-chitosan, pegylated chitosan (PEG-chitosan), mono-N-carboxymethyl chitosan (MCC), chitosan derivatives, and combinations thereof.

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