Chitosan related compositions and methods for delivery of nucleic acids and oligonucleotides into a cell

Abstract

Compositions of chitosan-based compounds and nucleic acid or oligonucleotide which are capable of delivery to a cell. Methods of preparation of the compositions. Methods of administering the compositions in vitro to cells in culture or in vivo to an organism.

What is claimed is:  
     
         1 . A composition comprising: 
 (a) a chitosan-based compound; and    (b) a nucleic acid or an oligonucleotide, wherein said composition is capable of delivering said nucleic acid or said oligonucleotide into a cell.    
     
     
         2 . The composition of    claim 1   , wherein said chitosan-based compound is chitin.  
     
     
         3 . The composition of    claim 1   , wherein said chitosan-based compound is a chitosan monomer.  
     
     
         4 . The composition of    claim 1   , wherein said chitosan-based compound is a chitosan oligomer.  
     
     
         5 . The composition of    claim 1    wherein said chitosan-based compound is able to form a complex with said nucleic acid or said oligonucleotide.  
     
     
         6 . The composition of    claim 1    wherein said chitosan-based compound is able to condense said nucleic acid.  
     
     
         7 . The composition of    claim 1   , wherein said composition has a diameter between 15 nm and 10,000 nm.  
     
     
         8 . The composition of    claim 1   , wherein said composition has a diameter between 15 nm and 1,000 nm.  
     
     
         9 . The composition of    claim 1   , wherein said composition has a pH in the range of 4.0 to 8.0.  
     
     
         10 . The composition of    claim 1   , wherein said composition has a net positive charge ratio.  
     
     
         11 . The composition of    claim 1   , wherein said composition has a net negative charge ratio.  
     
     
         12 . The composition of    claim 1   , wherein said chitosan-based compound has a molecular weight in the range of 5 kDA to 1000 kDa.  
     
     
         13 . The composition of    claim 8   , wherein said chitosan-based compound has a molecular weight in the range of 5 kDA to 600 kDa.  
     
     
         14 . The composition of    claim 1   , wherein said composition is suitable for use in vitro.  
     
     
         15 . The composition of    claim 1   , wherein said composition is suitable for use in vivo.  
     
     
         16 . The composition of    claim 1   , further comprising a cryoprotectant.  
     
     
         17 . The composition of    claim 1   , wherein said composition is capable of expressing said nucleic acid inside of said cell.  
     
     
         18 . The composition of    claim 1   , wherein said composition is capable of delivering said oligonucletide inside of said cell to function as an antisense molecule.  
     
     
         19 . The composition of    claim 1   , wherein said composition is capable of being lyophilized, stored, rehydrated, delivered to a cell, whereby said nucleic acid or said oligonucleotide is capable of being expressed inside of said cell.  
     
     
         20 . A method of using the composition of    claim 1    to deliver said nucleic acid or said oligonucleotide to said cell, which comprises the step of delivering said composition to said cell.  
     
     
         21 . The method of    claim 18   , wherein said cell is in vitro.  
     
     
         22 . The method of    claim 18   , wherein said cell is in vivo and said exposing step comprises administering said composition to an organism.  
     
     
         23 . The method of    claim 18   , wherein said cell has been removed from a living organism.  
     
     
         24 . A method of making the composition of    claim 1   , comprising the steps of: 
 (a) exposing said chitosan-based compound to an acid;    (b) filtering the acid treated product of step (a);    (c) adding the acid treated and filtered product of step (b) to said nucleic acid or said oligonucleotide in an acceptable pharmaceutical carrier.    
     
     
         25 . The method of    claim 22   , wherein said nucleic acid or said oligonucleotide is present in a concentration ranging from 10 to 4,000 μg per ml of said acceptable pharmaceutical carrier.  
     
     
         26 . The method of    claim 22   , wherein said nucleic acid or said oligonucleotide is present in a concentration ranging from 100 to 400 μg per ml of said acceptable pharmaceutical carrier.  
     
     
         27 . The method of    claim 22   , wherein said acid is acetic acid.  
     
     
         28 . The method of    claim 25   , wherein said acetic acid is present in a concentration between 0.2% v/v and 1.0% v/v.