High concentration chitosan-nucleic acid polyplex compositions
AssigneeenGene, Inc.
InventorsEric Hsu, Carlos Fleet, Anthony Cheung, Jun Gao
Life of this patent
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Abstract
The invention provides highly concentrated chitosan-nucleic acid polyplex compositions and dispersions, and methods for producing the compositions and dispersions. Methods of mixing the chitosan-nucleic acid polyplexes include an inline mixing of chitosan solution and nucleic acid solution, followed by further concentrating the dispersion of chitosan-nucleic acid polyplexes, optionally with an aggregation inhibitor. Further provides are methods for altering the diameter of chitosan-nucleic acid polyplexes.
Claims20
An isotonic composition comprising hydrated chitosan-nucleic acid polyplexes comprising chitosan molecules having an average molecular weight less than 250 kDa and an aggregation inhibitor having a concentration of between about 3% and 20% by weight selected from the group consisting of sucrose, trehalose, glycerol, fructose, and glucose, wherein said composition has a nucleic acid concentration greater than or equal to 0.5 mg/ml and less than or equal to about 1.5 mg/ml and is free of chitosan-nucleic acid polyplex precipitate, and wherein said chitosan-nucleic acid polyplexes have an N:P ratio greater than or equal to 2:1, and increase in average diameter by less than 100% at room temperature in 6 hours.
An isotonic pharmaceutical composition, comprising hydrated chitosan-nucleic acid polyplexes comprising chitosan molecules having an average molecular weight less than 250 kDa and an aggregation inhibitor having a concentration of between about 3% and 20% by weight selected from the group consisting of sucrose, trehalose, glycerol, fructose, and glucose wherein said composition has a nucleic acid concentration greater than or equal to 0.5 mg/ml and less than or equal to about 1.5 mg/ml and is free of chitosan-nucleic acid polyplex precipitate, wherein said chitosan-nucleic acid polyplexes comprise a therapeutic nucleic acid construct, and wherein said chitosan-nucleic acid polyplexes have an N:P ratio greater than or equal to 2:1, and increase in average diameter by less than 100% at room temperature in 6 hours.
Dependencies are inferred from the claim text.