Stable lipid-comprising drug delivery complexes and methods for their production
First Claim
1. A method for producing a noncovalent nucleic acid/lipid/polycation complex having a net positive charge at pH 6.0-8.0, the method comprising,admixing a cationic lipid and a polycation to form a lipid/polycation complex, andadmixing a nucleic acid with the lipid/polycation complex in a ratio of nucleic acid to lipid to polycation which results in the production of the nucleic acid/lipid/polycation complex,wherein the polycation is a polycationic peptide or a polycationic protein.
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Abstract
Novel stable, concentrated, biologically active and ready-to-use lipid-comprising drug delivery complexes and methods for their production are described. The biological activity of the complexes produced are comparable to the formulations prepared according to the prior art admixture method and upon purification, the complexes produced by the method of this invention are 50 to 500 fold more concentrated than the complexes formed by admixture. The method described herein provides for the large scale production of lipid-comprising drug delivery systems useful for gene therapy and other applications.
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Citations
59 Claims
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1. A method for producing a noncovalent nucleic acid/lipid/polycation complex having a net positive charge at pH 6.0-8.0, the method comprising,
admixing a cationic lipid and a polycation to form a lipid/polycation complex, and admixing a nucleic acid with the lipid/polycation complex in a ratio of nucleic acid to lipid to polycation which results in the production of the nucleic acid/lipid/polycation complex, wherein the polycation is a polycationic peptide or a polycationic protein.
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22. A method for delivering nucleic acid to a cell comprising,
admixing a cationic lipid and a polycation to form a lipid/polycation complex, admixing a nucleic acid with the lipid/polycation complex in a ratio of nucleic acid to lipid to polycation which results in the production of the nucleic acid/lipid/polycation complex, and contacting the cell with the nucleic acid/lipid/polycation complex, wherein the polycation is a polycationic peptide or a polycationic protein.
Specification