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AssigneeInex Pharmaceuticals Corporation
InventorsEllen K. Wasan, Marcel B. Bally, Michael J. Hope, Dorothy L. Reimer, Quet Fah Ahkong
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Methods of forming cationic liposome/nucleic acid complexes in which the complexes have a mean diameter of about 200 to about 300 nm are provided. The complexes are formed by combining a first solution of preformed cationic unilamellar liposomes with a mean diameter of from 100 to 150 nm, with a second solution of nucleic acid. Each of the solutions are equilibrated prior to mixing to temperatures of from 0.degree. C. to about 12.degree. C., preferably about 2.degree. C. to about 7.degree. C. The preformed cationic liposomes are typically prepared from an unsaturated cationic lipid, for example DODAC, DOTAP, DOTMA, DODAP, DMRIE, DORI, DOSPA and combinations thereof, and a neutral lipid, for example DOPE or cholesterol. The combination of the first and second solutions is typically carried out by gentle mixing over ice for a period of time of from about 10 to about 60 minutes.
A method of preparing cationic liposome/nucleic acid complexes comprising combining a first solution of preformed cationic liposomes with a second solution of nucleic acids, wherein each of said first and second solutions have been pre-equilibrated to temperatures of from 0.degree. C. to 12.degree. C., said preformed cationic liposomes being unilamellar, having a mean diameter of from 100 to 150 nm, and consisting essentially of unsaturated cationic lipids and neutral lipids selected from the group consisting of DOPE, cholesterol and combinations thereof.
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