Dissolvable film and method of manufacture
Dissolvable films for the administration of an active ingredient having a water solubility of less than about 1 g/4 mL at room temperature.
1 . An active-containing dissolvable film prepared by forming a mixture comprising an active ingredient and film-forming ingredients, coating the mixture onto a substrate material to form a film, and then drying the film to a moisture content of less than about 15 weight % moisture, said active ingredient having a water solubility of less than about 1 g/4 mL at room temperature and being present in the film in amounts sufficient to impart a desired action upon administration of a single dosage form of the active-containing dissolvable film.
2 . The film of claim 1 wherein the active ingredient has a water solubility of less than about 1 g/10 mL at room temperature.
3 . The film of claim 1 wherein the mixture is in the form of a solution.
4 . The film of claim 3 wherein a solution is formed upon the application of heat and/or agitation of the mixture.
5 . The film of claim 1 wherein the mixture is in the form a suspension.
6 . The film of claim 3 wherein said active ingredient is caffeine.
7 . The film of claim 6 comprising at least about 18% by dry weight of caffeine based on the weight of the final formulated film.
8 . The film of claim 7 comprising at least about 20% by dry weight of caffeine.
9 . The film of claim 8 comprising at least about 25% by dry weight of caffeine.
10 . The film of claim 1 wherein said film-forming ingredients comprise a starch component comprising at least about 85% modified starch.
11 . The film of claim 10 wherein the starch is selected from the group consisting of a hydroxyalkylated starch and a succinated starch.
12 . A method of making an active-containing dissolvable film comprising an active ingredient, the method comprising forming a mixture of an active ingredient and film-forming ingredients, coating the mixture onto a substrate material to form a film, and then drying the film to a moisture content of less than about 15 weight % moisture, said active ingredient having a water solubility of less than about 1 g/4 mL at room temperature and used in amounts sufficient to impart a desired action upon administration of a single dosage form of the active-containing dissolvable film.
13 . The method of claim 12 wherein the mixture is in the form of a solution or in the form of a suspension.
14 . A dissolvable caffeine-containing film comprising at least about 18% by dry weight of caffeine based on the weight of said film.
15 . A single dosage dissolvable film of claim 14 comprising from about 20 mg to about 30 mg of caffeine per single dosage film.
16 . A method of administering an active ingredient to an individual needing or desiring said active ingredient, said method comprising applying the active-containing dissolvable film of claim 1 to a moist area of an individual, upon which application the active is released.
17 . The method of claim 16 , wherein the film is applied to the tongue.
18 . The method of claim 16 , wherein the film is applied to traumatized tissue.
19 . The method of claim 18 wherein the traumatized tissue is skin.
20 . The method of claim 17 wherein the active ingredient is caffeine.