COCHLEATE COMPOSITIONS AND METHODS OF MAKING AND USING SAME

1 . A cochleate composition comprising a population of cochleates, wherein the cochleates comprise:

a) a negatively charged first lipid;

b) a cation, wherein the cation is a divalent cation or a higher valency cation selected from the group consisting of calcium, zinc, barium, and magnesium cations;

c) a second lipid; and

d) a biologically relevant molecule;

wherein the second lipid is a neutral or cationic lipid or sterol and the second lipid comprises up to 50% of the total lipid component of the cochleates.

2 - 3 . (canceled)

4 . The cochleate composition of claim 1 , wherein the second lipid is selected from the group consisting of phosphatidylcholine and sphingomyelin.

5 . The cochleate composition of claim 1 , wherein the second lipid comprises lipid capable of forming hydrogen bonds to the biologically relevant molecule.

6 . The cochleate composition of claim 1 , wherein the second lipid is embedded among the negatively charged first lipid.

7 - 9 . (canceled)

10 . The cochleate composition of claim 1 , wherein the negatively charged lipid comprises phosphatidylserine, dioleoyl PS (DOPS), and soybean-derived phosphatidyl serine (soy PS).

11 . The cochleate composition of claim 1 , wherein the cochleates further comprise a minor amount of a third lipid.

12 . The cochleate composition of claim 11 , wherein the third lipid is selected from the group consisting of a zwitterionic lipid, a PEGylated lipid, a cationic lipid, or a polycationic lipid.

13 - 14 . (canceled)

15 . The cochleate composition of claim 1 , wherein the biologically relevant molecule is hydrophilic.

16 - 18 . (canceled)

19 . The cochleate composition of claim 1 , wherein the biologically relevant molecule is at least one member selected from the group consisting of a drug, a vitamin, a mineral, a fatty acid, an amino acid, a saccharide, a polynucleotide, a polypeptide, an antigen, a nutrient and a flavor substance, wherein the drug is an antifungal agent; a non-steroidal anti-inflammatory agent; an anticancer agent; an antiviral, an anesthetic, or an anti-infectious agent, an immunosuppressant, a steroidal anti-inflammatory, a tranquilizer, and a vasodilatory agent.

20 . (canceled)

21 . The cochleate composition of claim 19 , wherein the drug is selected from the group consisting of amphotericin B and gentamicin.

22 . The cochleate composition of claim 19 , wherein the drug is an aminoglycoside.

23 . The cochleate composition of claim 22 , wherein the aminoglycoside is amikacin.

24 - 29 . (canceled)

30 . The cochleate composition of claim 1 , further comprising an aggregation inhibitor.

31 . The cochleate composition of claim 1 , wherein the cochleate composition contains sodium chloride.

32 . A pharmaceutical composition comprising an effective amount of the cochleate composition of claim 1 and a pharmaceutically acceptable carrier.

33 . A method of making the cochleate composition of claim 1 comprising:

a) mixing a biologically relevant molecule with a liposome comprising a negatively charged first lipid and a second lipid wherein the second lipid is a neutral or cationic lipid or sterol; and

b) adding a cation, wherein the cation is a divalent cation or a higher valency cation selected from the group consisting of calcium, zinc, barium, and magnesium cations, to make the cochleate composition,

wherein the second lipid comprises up to 50% of the total lipid component of the cochleates.

34 . The method of claim 33 , wherein the ratio of the total lipid to biologically relevant molecule is at least 4:1.

35 - 38 . (canceled)

39 . The method of claim 33 , wherein the calcium cation is provided from calcium chloride, wherein the calcium chloride concentration of the mixture is 2 mM to 10 mM.

40 - 41 . (canceled)

42 . The method of claim 33 , further comprising a step c), wherein an aggregation inhibitor is mixed with the cochleate compositions.

43 . (canceled)

44 . The method of claim 33 , wherein sodium chloride is mixed with the cochleate compositions, wherein the sodium chloride concentration of the mixture is 1 mM to 1 M.

45 - 46 . (canceled)

47 . A method of treatment comprising administering to a host in need thereof a pharmaceutically effective amount of the composition of claim 1 , wherein the host is selected from the group consisting of a cell, a cell culture, an organ, tissue, or an animal.

48 . (canceled)

49 . The method of treatment of claim 47 , wherein the administration is a mucosal route selected from the group consisting of oral, intranasal, intraocular, intraanal, intravaginal, and intrapulmonary.

50 - 79 . (canceled)