Claims

1. A method for delivery via the pulmonary system comprising: administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of particles comprising: a bioactive agent in association with a charged lipid wherein the charged lipid has an overall net charge which is opposite to the overall net charge of the agent upon association and wherein release of the agent is sustained.

2. The method of claim 1, wherein association of the agent and charged lipid comprises an ionic complexation.

3. The method of claim 2, wherein association of the lipid and agent further comprises hydrogen bonding.

4. The method of claim 1, wherein the charge ratio of lipid to bioactive agent is from about 0.25:1 to about 1:0.25.

5. The method of claim 4, wherein the charge ratio of lipid to bioactive agent is from about 0.5:1 to about 1:0.5.

6. The method of claim 5, wherein the charge ratio of lipid to bioactive agent is about 1:1.

7. The method of claim 1, wherein the bioactive agent is a protein.

8. The method of claim 7, wherein the protein is insulin.

9. The method of claim 8, wherein the sustained release is at least about 6 hours post administration.

10. The method of claim 1, wherein the bioactive agent is estrone sulfate.

11. The method of claim 1, wherein the bioactive agent is albuterol sulfate.

12. The method of claim 1, wherein the lipid possesses and overall net negative charge.

13. The method of claim 12, wherein the lipid is a 1,2-diacyl-sn-glycero-3-[phospho-rac-(1-glycerol)] and a 1,2-diacyl-sn-glycerol-3-phosphate.

14. The method of claim 13, wherein the 1,2-diacyl-sn-glycero-3-[phospho-rac-(1-glycerol)] lipid is represented by Formula I: wherein, R₁ and R₂ are independently an aliphatic group having from about 3 to about 24 carbons.

15. The method of claim 13, wherein the 1,2-diacyl-sn-glycero-3-[phospho-rac-(1-glycerol)] lipid is 1,2-distearoyl-sn-glycero-3-[phospho-rac-(1-glycerol)] (DSPG), 1,2-dimyristoyl-sn-glycero-3-[phospho-rac-(1-glycerol)] (DMPG), 1,2-dipalmitoyl-sn-glycero-3-phospho-rac-(1-glycerol)] (DPPG), 1,2-dilauroyl-sn-glycero-3-[phospho-rac-(1-glycerol)] (DLPG), 1,2-dioleoyl-sn-glycero-3-[phospho-rac-(1-glycerol)] (DOPG) or any combination thereof.

16. The method of claim 13, wherein the 1,2-diacyl-sn-glycerol-3-phosphate is represented by the Formula II: wherein, R₁ and R₂ are independently an aliphatic group having from about 3 to about 24 carbons.

17. The method of claim 13, wherein the 1,2-diacyl-sn-glycerol-3-phosphate lipid is 1,2-dimyristoyl-sn-glycero-3-phosphate (DMPA), 1,2-dipalmitoyl-sn-glycero-3-phosphate (DPPA), 1,2-dilauroyl-sn-glycero-3-phosphate (DLPA), 1,2-dioleoyl-sn-glycero-3-phosphate (DOPA), 1,2-distearoyl-sn-glycero-3-phosphate (DSPA) or any combination thereof.

18. The method of claim 1, wherein the particles have a tap density less than about 0.4 g/cm^3.

19. The method of claim 18, wherein the particles have a tap density less than about 0.1 g/cm^3.

20. The method of claim 1, wherein the particles have a median geometric diameter of from about 5 micrometers and about 30 micrometers.

21. The method of claim 1, wherein the particles have an aerodynamic diameter of from about 1 to about 5 microns.

22. The method of claim 21, wherein the particles have an aerodynamic diameter of from about 1 to about 3 microns.

23. The method of claim 22, wherein the particles have an aerodynamic diameter of from about 3 to about 5 microns.

24. The method of claim 1, wherein delivery to the pulmonary system includes delivery to the deep lung.

25. The method of claim 1, wherein delivery to the pulmonary system includes delivery to the central airways.

26. The method of claim 1, wherein delivery to the pulmonary system includes delivery to the upper airways.

27. The method of claim 1, wherein the particles further comprise a lipid having no overall net charge.

28. The method of claim 1, wherein the particles further comprise a carboxylic acid or salt thereof.

29. The method of claim 28, wherein the carboxylic acid includes at least two carboxyl groups.

30. The method of claim 1, wherein the particles further comprise a multivalent metal salt or ionic components thereof.

31. The method of claim 30, wherein the multivalent salt is a salt of an alkaline earth metal.

32. The method of claim 1, wherein the particles further comprise an amino acid.

33. The method of claim 32, wherein the amino acid is hydrophobic.

34. The method of claim 33, wherein the hydrophobic amino acid is leucine, isoleucine, alanine, valine, phenylalanine or any combination thereof.