Claims for Patent: 8,173,106

Summary for Patent: 8,173,106

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:	13/374,135
Patent Claims:	1. A method of delivering a composition of peptide or protein drug and a compound having enhanced gastrointestinal enzymatic inhibition property to an intestinal tract of an animal subject, the method comprising delivering said composition that is loaded in an enteric-coated capsule to said animal subject orally, wherein said compound is a PGA-complexone conjugate and wherein said composition inside the capsule being delivered to said intestinal tract without contacting an acidic gastric fluid of said animal subject. 2. The method of claim 1, wherein said capsule further comprises a pharmaceutically acceptable carrier, diluent, excipient, solubilizer, bubbling agent, or emulsifier. 3. The method of claim 1, wherein said PGA-complexone conjugate is chelated to gadolinium. 4. The method of claim 1, wherein said capsule further comprises at least one permeation enhancer. 5. The method of claim 4, wherein said permeation enhancer is selected from the group consisting of Ca.sup.2+ chatters, bile salts, surfactants, medium-chain fatty acids, phosphate esters, and chitosan. 6. The method of claim 5, 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. 7. The method of claim 1, wherein said drug is a pegylated drug. 8. The method of claim 1, wherein said drug is covalently attached with polyethylene glycol polymer chains. 9. The method of claim 1, wherein said drug is insulin, an insulin analog, or osteocalcin. 10. The method of claim 1, wherein said drug is an insulin sensitizer. 11. The method of claim 1, wherein said drug is an insulin secretagogue. 12. The method of claim 1, wherein said drug is GLP-1 or a GLP-1 analog. 13. The method of claim 1, wherein said drug is an inhibitor of dipeptidyl peptidase 4 (DIP-4 inhibitor). 14. The method of claim 1, wherein said drug is excnatide, liraglutide, albiglutide, lixisenatide, or taspoglutide. 15. 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. 16. The method of claim 1, wherein said PGA of the PGA-complexone conjugate is selected from the group consisting of .gamma.-PGA, .alpha.-PGA, PGA derivatives, salts of PGA, and combinations thereof. 17. The method of claim 1, wherein said drug is a monoclonal antibody. 18. The method of claim 1, wherein said drug is a growth hormone. 19. The method of claim 1, wherein said drug is an interferon, interleukin-11, or erythropoietin. 20. The method of claim 1, wherein said drug is an anti-inflammatory drug, an anti-epileptic drug, an antibiotic, or an Alzheimer's antagonist.

Details for Patent 8,173,106

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431	04/15/2014		2025-01-04
Sanofi-aventis U.s. Llc	ADLYXIN	lixisenatide	Injection	208471	07/27/2016		2025-01-04