Combination of Polychitosamine and Fibrate for the Prevention and Treatment of Hyperlipidemia
The present invention relates to pharmaceutical compositions comprising a fibrate (e.g. ciprofibrate, gemfibrozil, benzafibrate, and fenofibrate) and a polychitosamine (e.g. chitosan) having molecular weights of less than 650 Kda and degrees of deacetylation of from 70% to 100%. Uses of said compositions for the treatment of hyperlipidemia and associated conditions (e.g. hypercholesterolemia, atherosclerosis, coronary heart disease and cardiovascular disease) or as functional foods are also disclosed.
1 . A pharmaceutical dosage form comprising in combination:
a) an amount of fibrate;
b) an amount of polychitosamine having a molecular weight ranging from about 30 kDa to about 50 kDa; and optionally
c) a pharmaceutically acceptable carrier.
2 . (canceled)
3 . The dosage form according to claim 1 , wherein the polychitosamine has a degree of deacetylation ranging from about 80% to about 100%.
4 . The dosage form according to claim 3 , wherein the polychitosamine has a molecular weight of about 30 kDa and a degree of deacetylation of about 89%.
5 . The dosage form according to claim 4 , wherein the polychitosamine is Libracol®.
6 . The dosage form according to claim 3 , wherein the polychitosamine has a molecular weight of about 40 kDa and a degree of deacetylation of at least about 80%.
7 . The dosage form according to claim 1 , wherein the fibrate is fenofibrate.
8 . The dosage form according to claim 1 , wherein it comprises at least about 25 mg of fibrate.
9 . The dosage form according to claim 1 , wherein it comprises at least about 400 mg of polychitosamine.
10 - 22 . (canceled)
23 . A method for preventing or treating hyperlipidemia in a mammal comprising administering to said mammal an effective amount of the dosage form of claim 1 .
24 . The method according to claim 23 , wherein the amount of fibrate administered to the mammal is at least about 50 mg per day.
25 . The method according to claim 23 , wherein the amount of polychitosamine administered to the mammal is at least about 600 mg per day.
26 . The method according to claim 23 , wherein the mammal is a human.
27 . A method for lowering blood cholesterol in a mammal, wherein said method comprises the step of administering to said mammal an effective amount of the dosage form of claim 1 .
28 . The method according to claim 27 wherein the amount of fibrate administered to the mammal is at least about 50 mg per day.
29 . The method according to claim 27 wherein the amount of polychitosamine administered to the mammal is at least about 600 mg per day.
30 . The method according to claim 27 wherein the mammal is a human.
31 . A functional food comprising an effective amount of polychitosamine having a molecular weight ranging from about 30 kDa to about 50 kDa and an effective amount of fibrate.
32 . The functional food according to claim 31 selected from the group consisting of beverages, bread, grain, snack foods, prepared and packaged foods, condiments and dairy and dairy alternatives.
33 . (canceled)
34 . The functional food according to claim 31 wherein the polychitosamine has a degree of deacetylation ranging from about 80% to 100%.
35 . The functional food according to claim 31 wherein the polychitosamine has a molecular weight of about 30 kDa and a degree of deacetylation of about 89%.
36 . The functional food according to claim 35 wherein the polychitosamine is Libracol®.
37 . The functional food according to claim 31 wherein the fibrate is fenofibrate.
38 . The functional food according to claim 31 wherein it comprises at least about 25 mg of fibrate.
39 . The functional food according to claim 38 wherein it comprises at least about 400 mg of polychitosamine.
40 . A kit for the prophylaxis or treatment of hyperlipidemia in a mammal, the kit comprising a plurality of daily doses of dosage forms of a fibrate and a polychitosamine having a molecular weight ranging from about 30 kDa to about 50 kDa together with a treatment regimen instructions.
41 . The kit according to claim 40 , wherein the daily dose of fibrate is at least about 50 mg per day.
42 . The kit according to claim 41 , wherein the daily dose of polychitosamine is at least about 600 mg per day.
43 . The dosage form according to claim 1 , wherein the dosage form comprises a pharmaceutically acceptable carrier.
44 . The dosage form according to claim 3 , wherein it comprises at least about 25 mg of fibrate.
45 . The dosage form according to claim 44 , wherein it comprises at least about 400 mg of polychitosamine.
46 . The dosage form according to claim 45 , wherein the fibrate is fenofibrate.
47 . The dosage form according to claim 46 , wherein the polychitosamine has a molecular weight of about 30 kDa and a degree of deacetylation of about 89%.
48 . The dosage form according to claim 47 , wherein the polychitosamine is Libracol®.