THIN FILM WITH HIGH LOAD OF ACTIVE INGREDIENT
A method of preparing a thin film, the method comprising: (a) mixing a lipid, emulsifier, and solvent to provide a uniform first mixture; (b) contacting an active ingredient with the uniform first mixture to provide a thickened second mixture; (c) contacting a binder with the thickened second mixture to provide a slurry; and (d) hot extruding, casting, and condensing the slurry to provide the thin film; or cooling, shearing, mixing, casting, and condensing the slurry to provide the thin film.
1 . A thin film comprising:
(a) about 2-24 wt. % solvent,
(b) about 4-50 wt. % binder,
(c) about 0-10 wt. % flavoring agent,
(d) about 1-40 wt. % sweetener,
(e) about 4-22 wt. % lipid,
(f) about 3-22 wt. % emulsifier,
(g) about 0-1.0 wt. % dye or pigment,
(h) about 0-0.1 wt. % preservative,
(i) active ingredient present in at least about 25 wt. % and up to about 65 wt. %, and
(j) about 0-20 wt. % powder coating.
2 . The thin film of claim 1 , wherein the solvent is present in about 4-12 wt. %.
3 . The thin film of claim 1 , wherein the binder comprises at least one of pectin, microcrystalline cellulose, xanthan gum, locust bean gum, guar gum, gum arabic, gum tragacanth, gum karaya, beta glucan, glucomannan, tapioca starch, carrageenan, xanthan gum, gellan gum, alginic acid or sodium alginate, konjac gum, tara gum, chitosan, agar, maltodextrin, polyvinyl alcohol, pullulan, polycarbophil, povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxypropyl starch, polyacrylic acid, and polyethylene glycol.
4 . The thin film of claim 1 , wherein the binder is present in about 10-36 wt. %.
5 . The thin film of claim 1 , wherein the lipid comprises at least one of almond oil, argan oil, avocado oil, canola oil, cashew oil, castor oil, cocoa butter, coconut oil, colza oil, corn oil, cottonseed oil, grape seed oil, hazelnut oil, hemp oil, hydroxylated lecithin, lecithin, linseed oil, macadamia oil, mango butter, marula oil, mongongo nut oil, olive oil, palm kernel oil, palm oil, peanut oil, pecan oil, perilla oil, pine nut oil, pistachio oil, poppy seed oil, pumpkin seed oil, rice bran oil, safflower oil, sesame oil, Shea butter, soybean oil, sunflower oil, walnut oil, and watermelon seed oil.
6 . The thin film of claim 1 , wherein the lipid is present in about 10-18 wt. %.
7 . The thin film of claim 1 , wherein the emulsifier comprises at least one of glycerin, propylene glycol, and polyethylene glycol.
8 . The thin film of claim 1 , wherein the emulsifier is present in about 8-18 wt. %.
9 . The thin film of claim 1 , wherein the sweetener comprises at least one of sucralose, acesulfame potassium, ammonium glycyrrhizinate, naringin dihydrochalcone, neohesperidin dihydrochalcone, neotame, erythritol, xylitol, sucrose, sodium saccharine, stevia, alitame, fructose, and aspartame.
10 . The thin film of claim 1 , wherein the sweetener is present in about 6-14 wt. %.
11 . The thin film of claim 1 , wherein the dye or pigment is present in about 0.01-0.04 wt. %.
12 . The thin film of claim 1 , wherein the preservative is selected from at least one of benzoate salt, sorbate salt, and natamycin.
13 . The thin film of claim 1 , wherein the powder coating is selected from at least one of talc and microcrystalline cellulose.
14 . The thin film of claim 1 , wherein the powder coating is present in about 5-15 wt. %.
15 . The thin film of claim 1 , wherein the active ingredient is present in about 25-40 wt. %.
16 . The thin film of claim 1 , wherein the active ingredient is at least partially encapsulated by the lipid.
17 . The thin film of claim 1 , wherein at least about 75 wt. % of the active ingredient is encapsulated by the lipid.
18 . The thin film of claim 1 , wherein the active ingredient comprises at least one of sildenafil citrate, tadalafil, vitamin D (cholecalciferol), vitamin C (L-ascorbic acid), testosterone, fentanyl, ibuprofen, aspirin, ranitidine, loperamide, acetaminophen, aripiprazole, famotidine, morphine, ginseng , ondansetron, sucralose, caffeine, amino acid, and melatonin (N-acetyl-5-methoxytryptamine).
19 . The thin film of claim 1 , further comprising a powder coating present on at least one external surface of the thin film.
20 . The thin film of claim 1 , further comprising a powder coating present on two opposing external surfaces of the thin film.
21 . The thin film of claim 1 , further comprising a powder coating present on two opposing external surfaces of the thin film, wherein the powder coating comprises at least one of talc and microcrystalline cellulose.
22 . The thin film of claim 1 , wherein the active ingredient is present in about 25-45 wt. %.
23 . The thin film of claim 1 , wherein the active ingredient is present in at least about 30 wt. %.
24 . The thin film of claim 1 , wherein the active ingredient is present in at least about 35 wt. %.
25 . The thin film of claim 1 , wherein the active ingredient is present in at least about 40 wt. %.