Folic acid in solid dosage forms
View Patent ↗A nutritional tablet or caplet has a film coating that contains folic acid available for rapid release upon contact with gastric fluid. The film coating also includes a film forming polymer such as hydroxypropyl methylcellulose.
1. A method for preparing a film coated nutritional tablet or caplet comprising:
preparing an aqueous dispersion consisting essentially of a film forming polymer and folic acid;
coating a substrate tablet or caplet that contains at least one nutrient or active ingredient other than folic acid with the aqueous dispersion; and
drying the dispersion to form a tablet or caplet that is at least partially covered by a film coating that comprises folic acid.
2. The method of claim 1 wherein the film forming polymer is hydroxypropylmethylcellulose.
3. The method of claim 1 wherein the aqueous dispersion contains hydroxylated soy lecithin as a natural plasticizer.
4. The method of claim 1 wherein the aqueous dispersion comprises (w/w) about 8 to about 15 percent hydroxypropyl methylcellulose film forming polymer, about 0.05 to about 0.35 percent folic acid, and about 80 to about 90 percent purified water.
5. The method of claim 4 wherein the dispersion further contains a plasticizer.
6. The method of claim 5 wherein the plasticizer is of the group consisting of hydroxylated soy lecithin, castor oil, polyethylene glycol, propylene glycol, glycerine, and mixtures thereof.
7. The method of claim 1 wherein the aqueous dispersion comprises (w/w) about 10 to about 15 percent hydroxypropyl methylcellulose film forming polymer, about 0.20 to about 0.35 percent folic acid, and about 80 to about 90 percent purified water.
8. The method of claim 7 wherein the dispersion further contains a plasticizer.
9. The method of claim 8 wherein the plasticizer is of the group consisting of hydroxylated soy lecithin, castor oil, polyethylene glycol, propylene glycol, glycerine, and mixtures thereof.
10. The method of claim 1 wherein the aqueous dispersion is prepared and applied such that the resulting tablet or caplet has a film coating from which at least 50% of the folic acid dissolves in one hour in 900 ml of water at 37° C.
11. The method of claim 1 wherein the aqueous dispersion is prepared and applied such that the resulting tablet or caplet has a film coating from which at least 75% of the folic acid dissolves in one hour in 900 ml of water at 37° C.
12. The method of claim 1 wherein the aqueous dispersion is prepared and applied such that the resulting tablet or caplet has a film coating from which at least 50% of the folic acid dissolves in one hour in 900 ml of 0.05M citrate buffer at 37° C.
13. The method of claim 1 wherein the aqueous dispersion is prepared and applied such that the resulting tablet or caplet has a film coating from which at least 75% of the folic acid dissolves in one hour in 900 ml of 0.05M citrate buffer at 37° C.