Chewing Gum Comprising Chitosan For Use In Reduction Of The Level Of Free Phosphorus Compounds In The Digestive Juice

1 . A method of reducing the level of free phosphorus compounds in digestive juice to alleviate hyperphosphatemia by the use of chewing gum comprising:

a water insoluble gum base; and

a combination of:

chitosan as a phosphorus compound binding agent; and

at least one organic acid selected from the group consisting of ascorbic acid, malic acid, and tartaric acid.

2 . The method according to claim 1 , wherein the chewing gum comprises organic acid in an amount of 0.01 to 10% by weight of the chewing gum.

3 . The method according to claim 1 , wherein the chewing gum comprises organic acid in an amount of 0.05 to 2% by weight of the chewing gum.

4 . The method according to claim 1 , wherein said chewing gum is an extruded chewing gum.

5 . The method according to claim 4 , wherein said extruded chewing gum comprises gum base in an amount of 10 to 70% by weight of the chewing gum.

6 . The method according to claim 1 , wherein said chewing gum is compressed chewing gum.

7 . The method according to claim 6 , wherein said compressed chewing gum comprises gum base in an amount of 5 to 50% by weight of the chewing gum.

8 . The method according to claim 1 , wherein said chewing gum comprises sweetener in an amount of 5 to 80% of the chewing gum.

9 . The method according to claim 1 , wherein the chewing gum comprises chitosan in an amount of 0.1 to 10% by weight of the chewing gum.

10 . The method according to claim 1 , wherein the chewing gum comprises chitosan in an amount of 0.4 to 2% by weight of the chewing gum.

11 . The method according to claim 1 , wherein a chewing gum tablet comprises chitosan in an amount of 5 to 100 mg.

12 . The method according to claim 1 , wherein a chewing gum tablet comprises chitosan in an amount of 15 to 60 mg.

13 . The method according to claim 1 , wherein a ratio between an amount of chitosan and an amount of gum base in the chewing gum is between 0.001 to 0.15.

14 . The method according to claim 1 , wherein said chewing gum comprises a chewing gum tablet, wherein the chewing gum tablet is compressed and comprises chewing gum granules, wherein said chewing gum granules comprises gum base,

wherein said chewing gum tablet comprises a gum base content of at least 5% by weight of the tablet,

wherein said chewing gum tablet comprises chitosan in an amount of at least 1% by weight of the tablet,

wherein said chitosan has a molecular weight of above 30.000 Da,

wherein said chitosan has a degree of deacetylation above 85%, and

wherein said chewing gum tablet comprises ascorbic acid in an amount of at least 0.1% by weight of the tablet.

15 . The method according to claim 1 , wherein said chewing gum comprises a chewing gum tablet, wherein said chewing gum tablet has a gum base content of 5-90% by weight of the tablet,

wherein said chewing gum tablet comprises chitosan in an amount of at least 0.05% by weight of the tablet,

wherein said chitosan has a molecular weight of above 30.000 Da,

wherein said chitosan has a degree of deacetylation above 85%, and

wherein said chewing gum tablet comprises ascorbic acid in an amount of at least 0.1% by weight of the tablet.

16 . The method according to claim 1 , wherein said chewing gum comprises a chewing gum tablet, wherein said chewing gum tablet comprises chewing gum granules, wherein said chewing gum granules comprise gum base,

wherein said chewing gum tablet has a gum base content of 5-90% by weight of the tablet,

wherein said chewing gum tablet comprises chitosan in an amount of at least 0.1% by weight of the tablet,

wherein said chitosan has a molecular weight of above 30.000 Da,

wherein said chitosan has a degree of deacetylation above 85%, and

wherein said chewing gum tablet comprises ascorbic acid in an amount of at least 0.1% by weight of the tablet.

17 . A phosphorus compound binding agent in a slow release oral delivery system comprising the chewing gum used in the method of claim 1 for reducing the level of free phosphorus compounds in the digestive juice, for the support of treatment of patients with chronic renal insufficiency, wherein said phosphorus compound binding agent is chitosan.

18 . The phosphorus compound binding agent in a slow release oral delivery system according to claim 17 wherein said phosphorus compound binding agent is chitosan and wherein the chewing gum further comprises an organic acid.

19 . The method according to claim 5 wherein said extruded chewing gum comprises gum base in an amount of 15 to 60% by weight of the chewing gum.

20 . The method according to claim 19 wherein said extruded chewing gum comprises gum base in an amount of 35 to 50% by weight of the chewing gum.

21 . The method according to claim 7 wherein said compressed chewing gum comprises gum base in an amount of 8 to 40% by weight of the chewing gum.

22 . The method according to claim 21 wherein said compressed chewing gum comprises gum base in an amount of 10 to 30% by weight of the chewing gum.

23 . A method of reducing a level of free phosphorus compounds in digestive juice to alleviate hyperphosphatemia by the use of a chewing gum comprising:

a water insoluble gum base; and

a combination of

chitosan as a phosphorus compound binding agent; and

at least one organic acid.

24 . A method of reducing a level of free phosphorus compounds in digestive juice to alleviate hyperphosphatemia by the use of:

a combination of

chitosan as a phosphorus compound binding agent; and

at least one organic acid selected from the group consisting of ascorbic acid, malic acid, and tartaric acid,

comprised in a chewing gum comprising a water insoluble gum base.

25 . A method of reducing a level of free phosphorus compounds in digestive juice to alleviate hyperphosphatemia by the use of:

a combination of

chitosan as a phosphorus compound binding agent; and

at least one organic acid,

comprised in a chewing gum comprising a water insoluble gum base.