Use of Sucralose as a Granulating Agent
A method of making a granulation comprising the steps of (a) combining sucralose, a polar solvent, a wettable material and an active agent, thereby forming a mixture; and (b) drying the mixture, thereby forming the granulation.
1 . A method of making a granulation comprising the steps of:
(a) combining sucralose, a polar solvent, a wettable material and an active agent, thereby forming a mixture; and
(b) drying the mixture, thereby forming the granulation.
2 . The method of claim 1 , wherein the amount of sucralose present in the granulation is about 0.01 wt. % to about 5 wt. % based on the total weight of the granulation.
3 . The method of claim 1 , wherein the active agent and sucralose are present in a ratio of about 6.25:0.005 to about 6.25:0.05 active agent to sucralose.
4 . The method of claim 1 , wherein the granulation has a moisture content of about 0.1% to about 5% by weight.
5 . The method of claim 1 , wherein the active agent is a pharmaceutical active agent selected from the group consisting of diphenhydramine, pseudoephedrine, chlorpheniramine, cetirizine, loperamide and mixtures thereof.
6 . The method of claim 1 , wherein the sucralose is combined with the polar solvent.
7 . The method of claim 1 , wherein the sucralose is in dry form.
8 . The method of claim 1 , wherein the active agent is combined with the sucralose and polar solvent, and layered onto the wettable material.
9 . The method of claim 1 , further comprising the step of coating the granulation with a taste masking system.
10 . The method of claim 1 , wherein the polar solvent is water.
11 . The method of claim 1 , wherein the wettable material is selected from the group consisting of sucrose, mannitol, dextrose, lactose, lactitol, sorbitol, silicified microcrystalline cellulose, microcrystalline cellulose, and mixtures thereof.
12 . A method of increasing the mean particle size of a mixture of sucralose, a wettable material and an active agent comprising the steps of:
combining sucralose, a polar solvent, a wettable material and an active agent, thereby forming a mixture; and
drying the mixture and removing the polar solvent, thereby forming a granulation comprising a plurality of granules,
wherein the mean particle size of the granulation is at least about 1.0% greater than the mean particle size of the active agent, wettable material and sucralose.
13 . The method of claim 12 , wherein the average particle size of the granulation is at least about 2% greater than the average particle size of the mixture of the active agent, wettable material and sucralose as measured through an 18 mesh screen and on a 200 mesh screen.
14 . The method of claim 12 , wherein the sucralose has a concentration of about 0.01% to about 5% by weight based on the combined weight of the sucralose, the active agent and the wettable material after drying.
15 . The method of claim 12 , wherein the granulation is further blended with a matrix and compressed into a chewable tablet.
16 . The method of claim 15 , wherein the granulation is less than about 10 percent by weight of the chewable tablet.
17 . The method of claim 12 , wherein the granulation is further coated with a polymer coating.
18 . A method of making a granulation comprising the steps of:
(a) coating/layering a wettable material with a solution or suspension comprising sucralose, a polar solvent, and an active agent, thereby forming a mixture; and
(b) drying the mixture, thereby forming the granulation.
19 . A method of making a granulation comprising the steps of:
(a) combining sucralose, a polar solvent, a wettable material and an active agent, thereby forming a mixture; and
(b) drying the mixture, thereby forming the granulation,
wherein the granulation exhibits an increase in mean particle size of at least about 1% when compared to a substantially similar granulation composition absent the sucralose.