SOFT TABLET CONTAINING DEXTROSE MONOHYDRATE
The invention relates to a tablet capable of being chewed or disintegrated in the oral cavity, which comprises a pharmaceutically active ingredient, and a matrix comprising directly compressible dextrose monohydrate and sucralose, said tablet being substantially fat free and said matrix being substantially free of non-saccharide, water soluble polymeric binders.
1 .- 14 . (canceled)
15 . A method of improving the stability of a tablet, wherein the tablet comprises a pharmaceutically active ingredient, the method comprising the step of:
combining the pharmaceutically active ingredient in a matrix comprising directly compressible dextrose monohydrate and sucralose;
wherein the improvement in stability is evidenced by a reduction in browning or discoloration in the tablet.
16 . The method of claim 15 , wherein the active ingredient is selected from the group consisting of acetaminophen, ibuprofen, pseudoephedrine, dextromethorphan, diphenhydramine, chlorpheniramine, calcium carbonate, magnesium hydroxide, magnesium carbonate, magnesium oxide, aluminum hydroxide, mixtures thereof, and pharmaceutically acceptable salts thereof.
17 . The method of claim 15 , wherein the directly compressible dextrose monohydrate is from about 30% to about 75% by weight, based on the total weight of the tablet.
18 . The method of claim 15 , wherein the sucralose is from about 0.5% to about 5% by weight, based on the total weight of the tablet.
19 . The method of claim 15 , wherein the pharmaceutically active ingredient has an average particle size from about 100 to about 500 microns.
20 . The method of claim 15 , wherein the directly compressible dextrose monohydrate has an average particle size of about 100 to about 250 microns.
21 . The method of claim 15 , wherein the tablet is substantially free of aspartame, microcrystalline cellulose, triglycerides, non-saccharide, water soluble polymeric binders, or combinations thereof.
22 . The method of claim 15 , wherein the tablet further comprises at least one disintegrating agent selected from the group consisting of microcrystalline cellulose, starch, sodium starch glycolate, crosslinked polyvinylpyrrolidone, crosslinked carboxymethylcellulose, and mixtures thereof.
23 . The method of claim 15 , wherein the tablet further comprises at least one lubricant selected from the group consisting of magnesium stearate, stearic acid, and mixtures thereof
24 . The method of claim 15 , wherein the tablet is formed by direct compression.
25 . The method of claim 15 , wherein the tablet has a weight ratio of directly compressible dextrose monohydrate to sucralose that is at least about 25:1.