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Last Updated: March 28, 2024

Claims for Patent: 7,897,585


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Summary for Patent: 7,897,585
Title:Nanoparticles for protein drug delivery
Abstract: The invention discloses the nanoparticles composed of chitosan, poly-glutamic acid, and at least one anti-hemophilic factor or bioactive agent characterized with a positive surface charge and their enhanced permeability in oral drug delivery.
Inventor(s): Sung; Hsing-Wen (Hsinchu, TW), Tu; Hosheng (Newport Beach, CA)
Assignee: GP Medical, Inc. (Newport Beach, CA) National Tsing Hua University (Hsinchu, TW)
Application Number:12/378,976
Patent Claims:1. A method of promoting hemostasis caused by hemophilia in an animal subject, the method comprising administering bioactive nanoparticles consisting of an anti-hemophilic factor, positively charged chitosan, a zero-charge substance, and a negatively charged substrate, wherein a surface of said nanoparticles is dominated by the positively charged chitosan.

2. The method of claim 1, wherein said anti-hemophilic factor is a recombinant human coagulation factor VIIa (rFVIIa).

3. The method of claim 1, wherein said anti-hemophilic factor is a recombinant plasma/serum-free coagulation factor VIII.

4. The method of claim 1, wherein said anti-hemophilic factor is selected from the group consisting of Bioclate (manufactured by Aventis Behring), Helixate (manufactured by CSL Behring), Kogenate (manufactured by Bayer Healthcare), Recombinate (manufactured by Baxter Healthcare) Advate (manufactured by Baxter Healthcare), Alphanate (manufactured by Grifols SA), Hemofil-M (manufactured by Baxter Healthcare), Humate-P (manufactured by CLS Behrng), Koate (manufactured by Talecris Biotherapeutics), Monarc-M (manufactured by Baxter Healthcare), Monoclate-P (manufactured by CSL Behring), and Refacto (manufactured by Wyeth).

5. The method of claim 1, wherein the chitosan has a molecular weight about 80 kDa or less.

6. The method of claim 1, wherein said negatively charged substrate is .gamma.-PGA, .alpha.-PGA, derivatives of PGA, or salts of PGA.

7. The method of claim 1, wherein said nanoparticles have a mean particle size between about 50 and 400 nanometers.

8. The method of claim 1, wherein the chitosan is N-trimethyl chitosan, EDTA-chitosan, or chitosan derivatives.

9. The method of claim 1, wherein said zero-charge substance further comprises at least one permeation enhancer.

10. The method of claim 9, wherein said permeation enhancer is selected from the group consisting of bile salts, anionic surfactants, medium-chain fatty acids, phosphate esters, and chitosan derivatives.

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

12. The method of claim 11, wherein said nanoparticles are loaded in capsules or tablets.

13. The method of claim 12, wherein said capsules are treated with an enteric coating.

14. The method of claim 13, wherein said capsules further comprise a permeation enhancer.

15. The method of claim 14, wherein said capsules further comprise GRAS (Generally Recognized As Safe) material or pharmacopoeial excipients.

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

17. The method of claim 1, wherein said nanoparticles are formed via a simple and mild ionic-gelation method.

18. The method of claim 1, wherein at least a portion of said nanoparticles is crosslinked.

19. The method of claim 1, wherein said anti-hemophilic factor is a coagulation factor to treat the animal subject that lacks functional clotting factor VIII, factor IX, or factor XI.

Details for Patent 7,897,585

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc KOATE, KOATE-DVI antihemophilic factor (human) For Injection 101130 01/24/1974 ⤷  Try a Trial 2025-01-04
Baxalta Us Inc. HEMOFIL M antihemophilic factor (human) For Injection 101448 03/14/2001 ⤷  Try a Trial 2025-01-04
Grifols Biologicals Llc ALPHANATE antihemophilic factor/von willebrand factor complex (human) For Injection 102475 08/15/1978 ⤷  Try a Trial 2025-01-04
Grifols Biologicals Llc ALPHANATE antihemophilic factor/von willebrand factor complex (human) For Injection 102475 06/26/2014 ⤷  Try a Trial 2025-01-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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