METHODS AND COMPOSITIONS FOR DISRUPTING BIOFILM UTILIZING CHITOSAN-DERIVATIVE COMPOUNDS

1 - 93 . (canceled)

94 . A method of treating or preventing a complication of cystic fibrosis in a subject, the method comprising:

administering to the subject an effective amount of a composition comprising a soluble chitosan or derivatized chitosan, wherein the derivatized chitosan comprises a chitosan of the following formula (I):

wherein:

n is an integer between 20 and 6000; and

each R 1 is independently selected for each occurrence from hydrogen, acetyl, and a group of formula (II): wherein, formula (II) is selected from

wherein at least 25% of R 1 substituents are H, at least 1% of R 1 substituents are acetyl, and at least 2% of R 1 substituents are a group of formula (II),

thereby treating a complication of cystic fibrosis.

95 - 104 . (canceled)

105 . A nebulizer comprising a solution or powder of soluble derivatized chitosan, wherein the derivatized chitosan comprises a chitosan of the following formula (I):

wherein:

n is an integer between 20 and 6000; and

each R 1 is independently selected for each occurrence from hydrogen, acetyl, and a group of formula (II): wherein, formula (II) is selected from

wherein at least 25% of R 1 substituents are H, at least 1% of R 1 substituents are acetyl, and at least 2% of R 1 substituents are a group of formula (II).

106 - 111 . (canceled)

112 . The method of claim 94 , wherein the method comprises reducing the viscosity of a biofilm in the subject.

113 . The method of claim 112 , wherein the biofilm is in the respiratory system.

114 . The method of claim 94 , wherein the method comprises reducing the viscosity of viscous sputum associated with cystic fibrosis.

115 . The method of claim 94 , wherein the method comprises increasing the pourability of sputum compared to the sputum that has not been contacted with the composition.

116 . The method of claim 112 , wherein the method comprises reducing the viscosity of the biofilm by at least 50% compared to the biofilm that has not been contacted with the composition.

117 . The method of claim 112 , wherein the method comprises partially dissolving the biofilm compared to the biofilm that has not been contacted with the composition.

118 . The method of claim 94 , further comprising administering an additional agent.

119 . The method of claim 118 , wherein the additional agent is administered in a dosage to achieve a synergistic effect.

120 . The method of claim 118 , wherein the additional agent is administered together with the soluble derivatized chitosan.

121 . The method of claim 94 , further comprising administering an antibiotic, anti-inflammatory, or mucolytic compound to a subject in conjunction with, prior to, or subsequent to the administration of the composition.

122 . The method of claim 121 , wherein the antibiotic, anti-inflammatory, or mucolytic compound is administered in a dosage to achieve a synergistic effect.

123 . The method of claim 94 , wherein the composition is administered by inhalation.

124 . The method of claim 94 , wherein the effective amount is a therapeutically effective amount.

125 . The method of claim 124 , wherein the therapeutically effective amount is from about 10 to 250 μg/mL.

126 . The method of claim 94 , wherein the subject is infected with bacteria listed in Table 1, 2, 3, or 4.

127 . The method of claim 94 , wherein the derivatized chitosan is soluble in aqueous solution from about pH 6.8 to about pH 9.

128 . The method of claim 94 , wherein the molecular weight of the derivatized chitosan is between 10,000 and 100,000 Da.

129 . The method of claim 94 , wherein the chitosan is functionalized at between 20% and 30%.

130 . The method of claim 94 , wherein the degree of deacetylation (% DDA) of the derivatized chitosan is between 75% and 95%.

131 . The method of claim 94 , wherein the polydispersity index (PDI) of the derivatized chitosan is between 1.0 and 2.5.