CHEWABLE PHARMACEUTICAL PRODUCT FOR DELIVERY OF COLESEVELAM HYDROCHLORIDE

1 . A chewable pharmaceutical product comprising:

a matrix comprising: a binder, a bulking agent, a lubricant, a humectant, an emulsifier, and optionally one or more of a flavoring, a coloring, and an antioxidant, wherein the binder comprises one or more maltitol syrups that are present in the pharmaceutical product in an amount in the range of 60-70% by weight; and

colesevelam hydrochloride.

2 . The chewable pharmaceutical product of claim 1 , wherein the colesevelam hydrochloride is present in a dosage of 3.75 grams±10%.

3 . The chewable pharmaceutical product of claim 2 in the form of a bar having a unit weight of 30 g±10%.

4 . The chewable pharmaceutical product of claim 1 , wherein the colesevelam hydrochloride is present in a dosage of 625 milligrams±10%.

5 . The chewable pharmaceutical product of claim 4 in the form of a chew having a unit weight of 5 g±10%.

6 . The chewable pharmaceutical product of claim 1 , wherein the maltitol syrup comprises one or more maltitol syrups, which in combination have an effective solids content in the range of 81.5-83.3%.

7 . The chewable pharmaceutical product of claim 1 , wherein the bulking agent is sugar-free, comprising one or more of: sorbitol, mannitol, xylitol, lactitol, maltitol, isomalt, erythritol, polydextrose, maltodextrin, gelatin, gum acacia, gum Arabic, carrageenan, locust bean gum, and guar gum.

8 . The chewable pharmaceutical product of claim 1 , wherein the lubricant comprises palm oil, cocoa butter, sunflower oil, or combinations thereof.

9 . The chewable pharmaceutical product of claim 1 , wherein the emulsifier comprises: lecithin, distilled monoglycerides, mono-diglycerides, distilled propylene glycol monoester, succinylated monoglycerides, glyceryl monostearate, diacetyl tartaric acid esters of mono-diglycerides, glycerol lacto palmitates, polyglycerol esters, stearol lactylates, sorbitan esters of polysorbates, or combinations thereof.

10 . The chewable pharmaceutical product of claim 1 , wherein the humectant comprises: glycerin, propylene glycol, or combinations thereof.

11 . The chewable pharmaceutical product of claim 1 , comprising the flavoring that comprises: chocolate flavor, vanilla flavor, strawberry flavor, caramel flavor, or combinations thereof.

12 . The chewable pharmaceutical product of claim 1 comprising by weight of the pharmaceutical product:

(i) colesevelam hydrochloride in an amount of 3.75 grams±10%;

(j) maltitol syrup as the binder in an amount in the range of 63-66%;

(k) one or more of: maltodextrin and gum acacia as the bulking agent totaling an amount in the range of 5-15%;

(l) palm oil as the lubricant in an amount in the range of 1.5-6%;

(m) glycerin as the humectant in an amount in the range of 1-3%;

(n) lecithin as the emulsifier in an amount in the range of 1-2%;

(o) a flavoring in an amount in the range of 0.01-6%; and

(p) optionally one or more of a powdered sweetener, a coloring, and an antioxidant.

13 . The chewable pharmaceutical product of claim 1 comprising by weight of the pharmaceutical product:

(j) colesevelam hydrochloride in an amount of 12.5%;

(k) maltitol solids in an amount in the range of 52-54%;

(l) one or more of: maltodextrin and gum acacia as the bulking agent totaling an amount in the range of 5-15%;

(m) palm oil as the lubricant in an amount in the range of 1.5-6%;

(n) glycerin as the humectant in an amount in the range of 1-3%;

(o) lecithin as the emulsifier in an amount in the range of 1-2%;

(p) a flavoring in an amount in the range of 0.01-6%;

(q) water in an amount in the range of 11.5-12.5% and

(r) optionally one or more of a powdered sweetener, a coloring, and an antioxidant;

wherein ingredients (a)-(i) total 100%.

14 . A method of delivering colesevelam hydrochloride comprising: administering the chewable pharmaceutical product of claim 1 to a patient in need of glycemic control or lipid-lowering.

15 . The method of claim 14 , wherein the chewable pharmaceutical product is ingested once per day.