Stable lipid-comprising drug delivery complexes and methods for their production
First Claim
1. A noncovalent nucleic acid/lipid/polycation complex comprising a nucleic acid, at least one cationic lipid species, and a polycation, wherein the polycation is at least one protamine sulfate or chloride salt, a histone, a peptide comprising polylysine, or a peptide comprising a nuclear localization sequence of SV40 large T antigen, and wherein the noncovalent complex is formed by adding a nucleic acid to a solution comprising the cationic lipid species and the polycation.
5 Assignments
0 Petitions
Accused Products
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.
131 Citations
81 Claims
- 1. A noncovalent nucleic acid/lipid/polycation complex comprising a nucleic acid, at least one cationic lipid species, and a polycation, wherein the polycation is at least one protamine sulfate or chloride salt, a histone, a peptide comprising polylysine, or a peptide comprising a nuclear localization sequence of SV40 large T antigen, and wherein the noncovalent complex is formed by adding a nucleic acid to a solution comprising the cationic lipid species and the polycation.
-
11. A method for producing a noncovalent nucleic acid/lipid/polycation complex comprising a nucleic acid, at least one cationic lipid species, and a polycation, wherein the polycation is at least one protamine sulfate or chloride salt, a histone, a peptide comprising polylysine, or a peptide comprising a nuclear localization sequence of SV40 large T antigen.
the method comprising adding a nucleic acid to a solution comprising the cationic lipid species and the polycation to form the complex.
Specification