Claims for Patent: 8,236,752

Summary for Patent: 8,236,752

Title:	Pharmaceutical composition of nanoparticles
Abstract:	The invention relates to a method for treating disorders or diseases of a tight junction comprising delivering a pharmaceutical composition of nanoparticles to the tight junction, wherein the nanoparticles consist of positively charged chitosan, a negatively charged substrate, optionally a zero-charge compound, and at least one bioactive agent for treating said disorders or diseases of the tight junction of an animal subject.
Inventor(s):	Sung; Hsing-Wen (Hsinchu, TW), Sonaje; Kiran (Hsinchu, TW), Nguyen; Ho-Ngoc (Hsinchu, TW), Chuang; Er-Yuan (Hsinchu, TW), Tu; Hosheng (Newport Beach, CA)
Assignee:	GP Medical, Inc. (Newport Beach, CA) National Tsing Hua University (Hsinchu, TW)
Application Number:	13/453,149
Patent Claims:	1. A method of delivering at least one bioactive agent to an animal subject by circumventing a first-pass liver metabolism, the method comprising: (a) loading said bioactive agent in nanoparticles; and (b) delivering said nanoparticles via a parenteral route to said animal subject, wherein the nanoparticles consist of positively charged chitosan, a negatively charged substrate, optionally a zero-charge compound, and said bioactive agent. 2. The method of claim 1, wherein said parenteral route is a nasal pathway from the nose via olfactory mucosa to a brain tissue via cerebrospinal fluid (CSF). 3. The method of claim 1, wherein the negatively charged substrate is polyglutamic acid (PGA). 4. The method of claim 3, wherein said PGA is selected from the group consisting of .gamma.-PGA, .alpha.-PGA, derivatives of PGA, salts of PGA, and combinations thereof. 5. The method of claim 3, wherein said PGA is a PGA-complexone conjugate. 6. The method of claim 5, wherein said complexone of the PGA-complexone conjugate is selected from the group consisting of DTPA (diethylene triamine pentaacetic acid), EDTA (ethylene diamine tetra acetate), IDA (iminodiacetic acid), NTA (nitrilotriacetic acid), EGTA (ethylene glycol tetraacetic acid), BAPTA (1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid), DOTA (1,4,7,10-tetraazacyclododecane-N,N',N,N'-tetraacetic acid), and NOTA (2,2',2''-(1,4,7-triazonane-1,4,7-triyl)triacetic acid). 7. The method of claim 1, wherein said nanoparticles are treated with an enteric coating polymer. 8. The method of claim 1, wherein said zero-charge compound is a permeation enhancer. 9. The method of claim 8, wherein said permeation enhancer is selected from the group consisting of bile salts, surfactants, medium-chain fatty acids, phosphate esters, and chitosan. 10. 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. 11. The method of claim 1, wherein said bioactive agent is selected from the group consisting of an anti-epileptic drug, anti-inflammatory drug, meningitis antagonist, and anti-oxidant. 12. The method of claim 11, wherein said anti-inflammatory drug is selected from the group consisting of mesalazine, prednisone, a TNF inhibitor, azathioprine (Imuran), methotrexate, 6-mercaptopurine, nystatin, antifungal agent, itraconazole, and fluconazole. 13. The method of claim 1, wherein said bioactive agent is selected from the group consisting of an antagonist for treatment of multiple sclerosis, neuromyelitis optica, late-stage neurological trypanosomiasis, progressive multifocal leukoencephalopathy, HIV encephalitis, and Alzheimer's diseases. 14. The method of claim 1, wherein said nanoparticles are freeze-dried, thereby said nanoparticles being in a powder form. 15. The method of claim 1, wherein said freeze-dried nanoparticles are being re-constituted with sterile water prior to being delivered to nose of said animal subject. 16. The method of claim 1, wherein said nanoparticles are collapsed nanoparticles. 17. The method of claim 1, wherein said nanoparticles have a mean particle size between about 50 and 500 nanometers. 18. The method of claim 1, wherein said bioactive agent is insulin or an insulin analog. 19. The method of claim 1, wherein said bioactive agent is an anti-diabetic drug. 20. The method of claim 1, wherein said nanoparticles are formed via a simple and mild ionic-gelation process.

Details for Patent 8,236,752

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2025-01-04