Oral dissolvable film that includes plant extract
Films (ODFs) that include botanical extract are provided, as well as methods of making and using the same.
1. An oral dissolvable film with a mass of 100±10 mg and a thickness of up to about 20 mm, the oral dissolvable film consisting essentially of:
(a) about 2-24 wt. % of water,
(b) about 40-50 wt. % of a binder selected from the group consisting of pectin, microcrystalline cellulose, and a combination thereof;
(c) about 0.1-22 wt. % of a lipid selected from the group consisting of cocoa butter, lecithin, and a combination thereof;
(d) about 3-22 wt. % of emulsifier selected from the group consisting of glycerin, propylene glycol, polyethylene glycol, and combinations thereof;
(e) at least about 25 wt. % of a cannabis extract;
(f) greater than about 1 wt. % to about 10 wt. % of a flavoring agent selected from the group consisting of mint, spearmint, peppermint, and a combination thereof; and
(g) greater than about 1 wt, % to about 40 wt. % of a sweetener selected from the group consisting of sucralose, acesulfame potassium, and a combination thereof; wherein,
the cannabis extract is encapsulated by the lipid.
2. The oral dissolvable film of claim 1 , configured as a unit dose.
3. The oral dissolvable film of claim 1 , wherein the cannabis extract consists essentially of cannabidiol, tetrahydrocannabinol, or a combination thereof.
4. The oral dissolvable film of claim 1 , configured and formulated for the immediate release of the cannabis extract.
5. The oral dissolvable film of claim 1 , configured and formulated for the sustained release, delayed release, modified release, extended release, or controlled release of the cannabis extract.
6. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the oral dissolvable film has a dissolution of within about 90 seconds when placed in the oral cavity of a human.
7. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the oral dissolvable film has a dissolution of within about 60 seconds when placed in the oral cavity of a human.
8. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the oral dissolvable film has a dissolution of within about 45 seconds when placed in the oral cavity of a human.
9. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the cannabis extract consists essentially of cannabidiol, present in about 0.1-50 mg.
10. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the cannabis extract consists essentially of cannabidiol, present in about 0.5-40 mg.
11. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the cannabis extract consists essentially of tetrahydrocannabinol, present in about 0.1-50 mg.
12. The oral dissolvable film of claim 1 , configured as a unit dose, wherein the cannabis extract consists essentially of tetrahydrocannabinol, present in about 0.5-40 mg.
13. The oral dissolvable film of claim 1 , further consisting essentially of about 1 wt. % to about 20 wt. % of powder coating selected from the group consisting of microcrystalline cellulose, mint flavoring, sucralose, acesulfame potassium, and a combination thereof.
14. The oral dissolvable film of claim 1 , further consisting essentially of about 1 wt. % to about 2.0 wt. % of a dough conditioner selected from the group consisting of ethoxylated monoglycerides, ethoxylated diglycerides, and a combination thereof.
15. The oral dissolvable film of claim 1 , further consisting essentially of a dye or pigment selected from the group consisting of FD&C red, FD&C blue, FD&C green, FD&C yellow, and combinations thereof.
16. The oral dissolvable film of claim 1 , further consisting essentially of a preservative selected from the group consisting of sodium benzoate, methyl paraben, propyl paraben, sodium sorbate, and combinations thereof.