Patent ID: 7521187
Filing Date: 2009-04-21
Classification: A61K,A61P

Abstract:
1. A method of preparing a lyophilized composition comprising: (a) mixing (i) polyoxyethylene (POE) and polyoxypropylene (POP) blockcopolymer; (ii) a polynucleotide; (iii) a cationic surfactant selected from the group consisting of benzalkonium chloride (BAK), benethonium chloride, cetrimide, cetylpyridinium chloride, acetyl triethylammonium chloride, (±)-N-(Benzyl)-N,N dimethyl-2,3-bis(hexyloxy)-1-propanaminium bromide (Bn-DHxRIE), (±)-N-(2 Acetoxyethyl)-N,N-dimethyl-2,3-bis(hexyloxy)-1-propanaminium bromide (DHxRIE-OAc), (±)-N-(2-Benzoyloxyethyl)-N,N-dimethyl-2,3-bis(hexyloxy)-1 propanaminium bromide (DHxRIE-OBz) and (±)-N-(3-Acetoxypropyl)-N,N dimethyl-2,3-bis(octyloxy)-1-propanaminium chloride (Pr-DOctRIE-OAc); and (iv) a compound selected from the group consisting of monosaccharides, disaccharides, oligosaccharides, sorbitol, hydrophilic polymers, proteins and any combination thereof; at a temperature below the cloud point of said block copolymer to form a mixture; and (b) cold filtering the mixture, wherein filtration occurs at a temperature below the cloud point of the block copolymer; and (c) lyophilizing the mixture; wherein the lyophilized mixture form a stable, mono-dispersed composition upon reconstitution with an aqueous solution.