Film forming compositions containing sucralose
View Patent ↗Water soluble, gelatin-free dip coatings for substrates comprising a hydrocolloid, such as carrageenan, and sucralose.
1. A pharmaceutical dosage form comprising a core having an outer coating, said outer coating comprising, based upon the dry weight of the coating:
a) carrageenan; and
b) sucralose, wherein the coating is comprised of, based upon the total dry weight of the coating,
a) from about 0.5 percent to about 20 percent of carrageenan; and
b) from about 75 percent to about 99.5 percent of sucralose.
2. The pharmaceutical dosage form of claim 1 , wherein the coating is comprised of, based upon the total dry weight of the coating:
a) from about 5 percent to about 9 percent of carrageenan; and
b) from about 83 percent to about 95 percent of sucralose.
3. The pharmaceutical dosage form of claim 1 , wherein the carrageenan is kappa carrageenan.
4. The pharmaceutical dosage form of claim 1 wherein the coating further comprises, based upon the total dry weight of the coating, from about 0 to about 40 percent plasticizers.
5. The pharmaceutical dosage form of claim 4 wherein the plasticizers are selected from the group consisting of polyethylene glycol, glycerol, sorbitol, sucrose, corn syrup, fructose, dioctyl-sodium sulfosuccinate, triethyl citrate, tribuyl citrate, 1,2-propylene glycol, mono acetate of glycerol, diacetate of glycerol, triacetate of glycerol, natural gums, and mixtures thereof.
6. The pharmaceutical dosage form of claim 1 wherein the coating further comprises, based upon the total dry weight of the coating, from about 0 percent to about 14 percent of a coloring agent.
7. The pharmaceutical dosage form of claim 6 wherein the coloring agent is selected from the group consisting of azo dyes, quinopthalone dyes, triphenylmethane dyes, xanthene dyes, indigoid dyes, iron oxides, iron hydroxides, titanium dioxide, natural dyes, and mixtures thereof.
8. The pharmaceutical dosage form of claim 1 further comprising a plurality of outer coatings, wherein at least a first portion of the dosage form is comprised of a first outer coating and at least a second portion of the dosage form is comprised of a second outer coating.
9. The pharmaceutical dosage form of claim 8 wherein the second outer coating is visually distinct from the first outer coating.
10. A pharmaceutical dosage form comprising a core, a subcoating substantially covering said core, and an outer coating substantially covering said subcoating, wherein the outer coating is comprised of, based upon the dry weight of the outer coating,
a) from about 0.5 percent to about 20 percent of carrageenan; and
b) from about 75 percent to about 99.5 percent of sucralose.
11. The coated dosage form of claim 10 wherein the subcoating comprises cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.
12. The dosage form of claim 1 having a surface gloss of at least about 150 gloss units.
13. The dosage form of claim 2 having a surface gloss of at least about 150 gloss units.
14. The pharmaceutical dosage form of claim 1 comprising an effective amount of a pharmaceutical active ingredient, wherein said dosage form meets USP dissolution requirements for immediate release forms of said pharmaceutical active ingredient.
15. A method of making coated tablets comprising dip coating tablets with an aqueous dispersion under conditions sufficient to form a coating on the tablets, said aqueous dispersion comprising:
a) solvent;
b) carrageenan; and
c) sucralose, wherein the coating is comprised of, based upon the total dry weight of the coating,
i) from about 0.5 percent to about 20 percent of carrageenan; and
ii) from about 75 percent to about 99.5 percent of sucralose.
16. The pharmaceutical dosage form of claim 1 wherein the coating further comprises, based upon the total weight of the coating, from about 0.001 percent to about 1 percent of a film former.
17. The pharmaceutical dosage form of claim 16 wherein the film former is selected from the group consisting of cellulose, starch, polyvinylpyrrolidone, derivatives and mixtures thereof.
18. The pharmaceutical dosage form of claim 1 , wherein the coating is comprised of less than about 5% of cations, based upon the total weight of the coating.