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Last Updated: March 28, 2024

Claims for Patent: 8,114,380


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Summary for Patent: 8,114,380
Title:Pharmaceutical composition of nanoparticles for protein drug delivery
Abstract: The invention discloses a pharmaceutical composition of bioactive nanoparticles composed of chitosan, poly-glutamic acid, and a bioactive agent for oral delivery. The chitosan-based nanoparticles are characterized with a positive surface charge and enhanced permeability for oral drug delivery.
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:13/199,736
Patent Claims:1. A composition of nanoparticles for treatment of an inflammatory disease of an animal subject, the bioactive nanoparticles consisting of at least one anti-inflammatory agent, positively charged chitosan, optionally a zero-charge substance and a negatively charged substrate of polyglutamic acid (PGA), wherein said negatively charged substrate is neutralized with a portion of said positively charged chitosan in a core portion of said nanoparticles.

2. The composition of claim 1, wherein said anti-inflammatory agent is a monoclonal antibody.

3. The composition of claim 1, wherein said anti-inflammatory agent is selected from the group consisting of infliximab, adalimumab, gemtuzumab ozogamicin, and trastuzumab.

4. The composition of claim 1, wherein said chitosan is N-trimethyl chitosan, EDTA-chitosan, low molecular weight chitosan, PEG-chitosan, mono-N-carboxymethyl chitosan, chitosan derivatives, or combinations thereof.

5. The composition of claim 1, wherein said nanoparticles are formulated into a tablet or pill configuration.

6. The composition of claim 5, wherein said tablet or pill is treated with an enteric coating polymer.

7. The composition of claim 1, wherein said nanoparticles are encapsulated in a capsule.

8. The composition of claim 7, wherein said capsule further comprises a pharmaceutically acceptable carrier, diluent, excipient, solubilizer, bubbling agent, or emulsifier.

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

10. The composition of claim 7, wherein said capsule further comprises at least one permeation enhancer.

11. The composition of claim 10, wherein said permeation enhancer is selected from the group consisting of Ca.sup.2+ chelators, bile salts, surfactants, medium-chain fatty acids, phosphate esters, chitosan, and chitosan derivatives.

12. The composition of claim 1, wherein said nanoparticles are freeze-dried, thereby said nanoparticles being in a powder form.

13. The composition of claim 1, wherein said nanoparticles are mixed with trehalose and then freeze-dried, thereby said nanoparticles being in a powder form.

14. The composition of claim 1, wherein said nanoparticles are treated with an enteric coating polymer.

15. The composition of claim 1, wherein said PGA is selected from the group consisting of a PGA-complexone conjugate, .gamma.-PGA, .alpha.-PGA, derivatives of PGA, salts of PGA, and combinations thereof.

16. The composition of claim 15, wherein the PGA-complexone conjugate has chelated gadolinium.

17. The composition of claim 1, wherein said zero-charge substance is a permeation enhancer.

18. The composition of claim 1, wherein said inflammatory disease is an inflammatory bowel disease.

19. The composition of claim 1, wherein the inflammatory disease is a Crohn's disease or ulcerative colitis.

20. The composition of claim 1, wherein the anti-inflammatory agent is selected from the group consisting of nystatin, antifungal agent, itraconazole, fluconazole, mesalazine, prednisone, a TNF inhibitor, azathioprine (Imuran), methotrexate, and 6-mercaptopurine.

Details for Patent 8,114,380

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2025-01-04
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2025-01-04
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 02/10/2017 ⤷  Try a Trial 2025-01-04
Abbvie Inc. HUMIRA adalimumab Injection 125057 12/31/2002 ⤷  Try a Trial 2025-01-04
Abbvie Inc. HUMIRA adalimumab Injection 125057 02/21/2008 ⤷  Try a Trial 2025-01-04
Abbvie Inc. HUMIRA adalimumab Injection 125057 04/24/2013 ⤷  Try a Trial 2025-01-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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