# US 10,307,397 B2 · Oral dissolvable film that includes plant extract

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- Number: US 10,307,397 B2
- Document ID: US10307397B2
- Status: Granted
- Kind: B2
- Application number: 14/810,595
- Filed: 2015-07-28
- Published: 2016-02-25
- Granted: 2019-06-04
- Earliest claimed: 2014-07-28
- Assignees: Concept Matrix Solutions
- Applicants: Concept Matrix Solutions
- Inventors: Eric Allen; Robert Davidson; Tony LaRosa; David Reid
- Web page: https://patentgrep.com/patent/US10307397B2

## CPC

- A61K 31/366: having six-membered rings, e.g. delta-lactones
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 36/3482: {Cannabis}
- A61K 36/67: Piperaceae (Pepper family), e.g. Jamaican pepper or kava
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Films (ODFs) that include botanical extract are provided, as well as methods of making and using the same.

## Claims

### Claim 1

An oral dissolvable thin film comprising effective amounts of:
(a) water;
(b) a binder selected from the group consisting of pectin, microcrystalline cellulose, and combinations thereof;
(c) a lipid, wherein the lipid comprises cocoa butter and lecithin;
(d) an emulsifier, wherein the emulsifier comprises glycerin;
(e) at least one cannabinoid, present in an amount of at least about 30 wt. % of the oral dissolvable thin film;
(f) a flavoring agent selected from the group consisting of mint flavoring, spearmint flavoring, peppermint flavoring, and combinations thereof;
(g) a sweetener selected from the group consisting of sucralose, acesulfame potassium, and combinations thereof; and
(h) a powder coating on at least one external surface of the oral dissolvable thin film wherein:
at least about 10 wt. % of the at least one cannabinoid is encapsulated by the lipid,
the oral dissolvable thin film has a thickness of about 0.01 mm to about 20 mm, and
the oral dissolvable thin film has a rapid dissolution of about 30-300.

### Claim 2 (depends on 1)

The oral dissolvable film of claim 1, wherein the at least one cannabinoid comprises less than about 1 wt. % plant waxes.

### Claim 3 (depends on 1)

The oral dissolvable film of claim 1, wherein the at least one cannabinoid comprises less than about 1 wt. % plant lipids.

### Claim 4 (depends on 1)

The oral dissolvable film of claim 1, wherein the at least one cannabinoid comprises less than about 1 wt. % plant pigments.

### Claim 5 (depends on 1)

The oral dissolvable film of claim 1, wherein the at least one cannabinoid comprises less than about 1 wt. % chlorophylls.

### Claim 6 (depends on 1)

The oral dissolvable film of claim 1, wherein at least about 50 wt. % of the at least one cannabinoid is encapsulated by the lipid.

### Claim 7 (depends on 1)

The oral dissolvable film of claim 1, wherein the at least one cannabinoid is present in an amount of at least about 35 wt. % of the thin film.

### Claim 8 (depends on 1)

The oral dissolvable film of claim 1, configured and formulated for the immediate release (IR) of the at least one cannabinoid.

### Claim 9 (depends on 1)

The oral dissolvable film of claim 1, configured and formulated for the sustained release (SR), delayed release (DR), modified release (MR), extended release (XR), or controlled release (CR) of the at least one cannabinoid.

### Claim 10 (depends on 1)

The oral dissolvable film of claim 1, further comprising a dough conditioner selected from the group consisting of glycerin, ethoxylated monoglycerides, ethoxylated diglycerides, and combinations thereof.

### Claim 11 (depends on 1)

The oral dissolvable film of claim 1 wherein the pectin is genu pectin.

### Claim 12 (depends on 1)

The oral dissolvable film of claim 1 wherein the at least one cannabinoid is selected from the group consisting of tetrahydrocannabinol (THC), cannabidiol (CBD), and combinations thereof.

### Claim 13

An oral dissolvable thin film comprising effective amounts of:
(a) about 2 wt. % to 24 wt. % of water;
(b) about 40 wt. % to 50 wt. % of a binder selected from the group consisting of pectin, microcrystalline cellulose, and combinations thereof;
(c) about 0.1 wt. % to 22 wt. % of a lipid, wherein the lipid comprises cocoa butter and lecithin;
(d) about 3 wt. % to 22 wt. % of an emulsifier, wherein the emulsifier comprises glycerin;
(e) at least about 30 wt. % of at least one cannabinoid;
(f) greater than 0 wt. % to about 10 wt. % of a flavoring agent selected from the group consisting of mint flavoring, spearmint flavoring, peppermint flavoring, and combinations thereof;
(g) greater than 0 wt. % to about 40 wt. % of a sweetener selected from the group consisting of sucralose, acesulfame potassium, and combinations thereof;
(h) greater than 0 wt. % to about 20 wt. % of a powder coating, wherein powder coating is present on at least one external surface of the oral dissolvable thin film; and
(i) a preservative; wherein:
at least about 10 wt. % of the at least one cannabinoid is encapsulated by the lipid,
the oral dissolvable thin film has a thickness of about 0.01 mm to about 20 mm, the oral dissolvable thin film has a rapid dissolution of about 30-300, and the at least one cannabinoid comprises less than about 1 wt. % plant waxes, less than about 1 wt. % plant lipids, less than about 1 wt. % plant pigments, less than about 1 wt. % chlorophylls.

### Claim 14 (depends on 1, 13)

The oral dissolvable thin film of claim 1 or 13, further comprising an absorption enhancer.

### Claim 15 (depends on 1)

The oral dissolvable thin film of claim 1, further comprising a preservative.