Nanoparticles for protein drug delivery
View Patent ↗The invention discloses nanoparticles composed of chitosan, poly-glutamic acid, and at least one bioactive agent characterized with a positive surface charge. The bioactive agent is hydrophobic or lipophilic in nature and is associated with micelles before being encapsulated in nanoparticles.
1. A pharmaceutical composition of nanoparticles, said nanoparticles consisting of a positively charged chitosan, a negatively charged substrate, optionally a zero-charge compound, and micelles.
2. The pharmaceutical composition of claim 1 , wherein said nanoparticles have a mean particle size between about 50 and 400 nanometers.
3. The pharmaceutical composition of claim 1 , wherein said chitosan is N-trimethyl chitosan, EDTA-chitosan, low molecular weight chitosan, chitosan derivatives, or combinations thereof.
4. The pharmaceutical composition of claim 1 , wherein said nanoparticles are formed via a simple and mild ionic-gelation process.
5. The pharmaceutical composition of claim 1 , wherein said nanoparticles are formulated into a tablet or pill configuration.
6. The pharmaceutical composition of claim 5 , wherein said tablet or pill is treated with an enteric coating.
7. The pharmaceutical composition of claim 1 , wherein said nanoparticles are encapsulated in a capsule.
8. The pharmaceutical composition of claim 7 , wherein said capsules further comprises a pharmaceutically acceptable carrier, diluent, or excipient.
9. The pharmaceutical composition of claim 8 , wherein said excipient further comprises at least a solubilizer, bubbling agent, or emulsifier.
10. The pharmaceutical composition of claim 7 , wherein said capsules is treated with an enteric coating.
11. The pharmaceutical composition of claim 7 , wherein said capsules further comprises at least one permeation enhancer.
12. The pharmaceutical composition of claim 11 , wherein said permeation enhancer is selected from the group consisting of Ca 2+ chelators, bile salts, anionic surfactants, medium-chain fatty acids, phosphate esters, chitosan, and chitosan derivatives.
13. The pharmaceutical composition of claim 1 , wherein said micelles contain at least one bioactive agent.
14. The pharmaceutical composition of claim 1 , wherein said substrate is a PGA-complexone conjugate.
15. The pharmaceutical composition of claim 1 , wherein said nanoparticles are freeze-dried, thereby said nanoparticles being in a powder form.
16. The pharmaceutical composition of claim 1 , wherein said nanoparticles are mixed with trehalose and then freeze-dried, thereby said nanoparticles being in a powder form.
17. The pharmaceutical composition of claim 1 , wherein said micelles are made via an emulsion process, an microemulsion process or self-emulsifying process.
18. The pharmaceutical composition of claim 13 , wherein said at least one bioactive agent is a lipophilic or hydrophobic bioactive agent.
19. The pharmaceutical composition of claim 1 , wherein said zero-charge compound is a permeation enhancer.
20. The pharmaceutical composition of claim 1 , wherein said micelles are oil-in-water micelles or water-in-oil micelles.