Claims
- 1. A method for preparing nanoparticles of a therapeutic, prophylactic or diagnostic agent, comprising
dissolving the agent in a solvent to form a first solution, providing a non-solvent for the agent which is miscible with the solvent, and mixing the first solution with the non-solvent to form nanoparticles of the therapeutic, prophylactic or diagnostic agent, wherein the nanoparticles form a population of which at least 95% has a diameter of less than one micron.
- 2. The method of claim 1, further comprising adding a surfactant or excipient.
- 3. The method of claim 2, wherein the surfactant or excipient is added to the solvent.
- 4. The method of claim 2, wherein the surfactant or excipient is added to the non-solvent.
- 5. The method of claim 2, wherein the surfactant or excipient is added to the nanoparticles after their formation.
- 6. The method of claim 1, wherein the agent is selected from the group consisting of small-molecule drugs, proteins, lipids, polysaccharides, proteoglycans, and polynucleotides.
- 7. The method of claim 1, wherein the agent is soluble in water to less than about 0.1% w/v at room temperature.
- 8. The method of claim 1, wherein the agent is sufficiently hydrophobic to be insoluble in water.
- 9. The method of claim 1, further comprising collecting the nanoparticles by centrifugation, filtration, lyophilization, or spray drying.
- 10. The method of claim 1, wherein less than about 1% of the nanoparticles have a diameter of greater than about 1 micron.
- 11. A population comprising at least 95% nanoparticles of a therapeutic, diagnostic or prophylactic agent having a diameter of less than one micron.
- 12. The population of claim 11, wherein the agent is selected from the group consisting of small-molecule drugs, proteins, lipids, polysaccharides, proteoglycans, and polynucleotides.
- 13. The population of claim 11, wherein the agent is soluble in water to less than about 0. 1% w/v at room temperature.
- 14. The population of claim 11, wherein the agent is sufficiently hydrophobic to be insoluble in water.
- 15. The population of claim 11 wherein at least 99% of the nanoparticles have a diameter of less than one micron.
- 17. The formulation of claim 11 further comprising bioadhesive enhancing agents.
- 18. The formulation of claim 11 further comprising a dispersant.
- 19. The formulation of claim 11 further comprising a polymer.
- 20. The formulation of claim 11 comprising a polymer encapsulated agent having bioadhesive agent bound thereto or dispersed therein.
- 21. The formulation of claim 17 wherein the bioadhesive agent is selected from the group consisting of bioadhesive metal compounds and bioadhesive organic molecules.
- 22. The formulation of claim 11, wherein the nanoparticles are formed by a method comprising
dissolving the bioactive agent in a solvent to form a first solution; providing a non-solvent for the bioactive agent, wherein the non-solvent is miscible with the solvent; and mixing the first solution with the non-solvent to form nanoparticles.
- 23. A nano or microparticulate formulation for oral administration of a taxane providing a bioavailability of at least 5% of the bioavailability of the taxane when administered intravenously.
- 24. The formulation of claim 23 wherein the taxane is paclitaxel.
- 25. The formulation of claim 23 wherein the taxane is docetaxel.
- 26. The formulation of claim 23 wherein 90%, by volume or number, of the nanoparticles and microparticles have a diameter of less than five microns.
- 27. The formulation of claim 23 wherein 90%, by volume or number, of the nanoparticles and microparticles have a diameter of less than one micron.
- 28. The formulation of claim 23 wherein the taxane is present in a drug loading of up to 70% by weight.
- 29. The formulation of claim 23 wherein the taxane is present in a drug loading of between approximately 30 and 70% by weight.
- 30. The formulation of claim 23 further comprising a surfactant or excipient.
- 31. A method for treating a patient comprising administering the nanoparticle formulation of claim 11 or 23 to a patient.
- 32. The method of claim 31, wherein the formulation is selected from the group consisting of oral formulations, aerosols, topical formulations, parenteral formulations, and implantable compositions.
- 33. The method of claim 31 wherein the formulation is administered orally.
- 34. The method of claim 31 wherein the formulation is administered to the pulmonary system.
Parent Case Info
[0001] This application claims priority to U.S. Ser. No. 60/423,093 filed Oct. 30, 2002, and U.S. Ser. No. 60/490,343 filed Jul. 25, 2003.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60423093 |
Oct 2002 |
US |
|
60490343 |
Jul 2003 |
US |