# US 10,307,394 B2 · Dosage delivery film

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- Number: US 10,307,394 B2
- Document ID: US10307394B2
- Status: Granted
- Kind: B2
- Application number: 16/058,669
- Filed: 2018-08-08
- Published: 2018-12-06
- Granted: 2019-06-04
- Earliest claimed: 2017-06-01
- Assignees: Spartak LLC
- Applicants: Spartak LLC
- Inventors: Sergey Y. Chistov
- Web page: https://patentgrep.com/patent/US10307394B2

## CPC

- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 31/343: condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 47/08: containing oxygen, {e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/40: Cyclodextrins; Derivatives thereof
- 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

A dosage delivery film composition containing a botanical drug substance formable into a bioerodible dosage delivery film, the dosage delivery film composition including: (i) one or more of: a polymer, a plasticizer, a defoamer, or an antioxidant; (ii) a cannabinoid-cyclodextrin-terpene complex or a cannabinoid-terpene-surfactant micelle, and (iii) optionally, one or more of: a taste mask, a vasodilator, or a lipophilic vehicle to transport the botanical drug substance across the mucous membrane.

## Claims

### Claim 1

A composition comprising:
a cannabinoid-cyclodextrin complex including a cannabinoid associated with a β-cyclodextrin; and
a cannabinoid micelle admixed with said cannabinoid-β-cyclodextrin complex, said cannabinoid micelle consisting essentially of cannabinoid having an outer hydrophilic surfactant shell.

### Claim 2 (depends on 1)

The composition of claim 1, wherein said cannabinoid is selected from the group consisting of: cannabinol, cannabinolic acid, Δ(9)-tetrahydrocannabinol, Δ(9)-tetrahydrocannabinolic acid, Δ(9)-cannabidiol, Δ(9)-tetrahydrocannabidiolic acid, Δ(8)-tetrahydrocannabinol, Δ(8)-tetrahydrocannabinolic acid, Δ(8)-tetrahydrocannabidiol, Δ(8), tetrahydrocannabidiolic acid, Δ(9)-tetrahydrocannabivarin, cannabigerol, cannabidigerolic acid, cannabichromene, cannabichromenic acid, cannabicyclol, cannabicyclolic acid, cannabielsoin, cannabitriol, and Nabilone, or combinations thereof.

### Claim 3 (depends on 1)

The composition of claim 1, wherein said β-cyclodextrin is selected from the group consisting of: hydroxypropyl-β-cyclodextrin, sulfobutylether-β-cyclodextrin, maltosyl-β-cyclodextrin, dimethyl-β-cyclodextrin, trimethyl-β-cyclodextrin, randomly methylated-β-cyclodextrin, or combinations thereof.

### Claim 4 (depends on 1)

The composition of claim 1, wherein said β-cyclodextrin consists of randomly-methylated β-cyclodextrin or hydroxypropyl-βcyclodextrin.

### Claim 5 (depends on 1)

The composition of claim 1, wherein said cannabinoid associated with said β-cyclodextrin has a wt/wt ratio of about 1:1 to about 1:4.

### Claim 6 (depends on 1)

The composition of claim 1, wherein said diameter of said cannabinoid micelle is selected from the group consisting of: about 41 nm to about 45 nm, about 42.5 nm to about 47.5 nm, about 45 nm to about 50 nm, about 47.5 nm to about 52.5 nm, about 50 nm to about 55 nm, about 52.5 nm to about 57.5 nm, about 55 nm to about 60 nm, about 57.5 nm to about 62.5 nm, about 60 nm to about 65 nm, about 62.5 nm to about 67.5 nm, about 65 nm to about 70 nm, about 67.5 nm to about 72.5 nm, about 70 nm to about 75 nm, about 72.5 nm to about 77.5 nm, about 75 nm to about 80 nm, about 77.5 nm to about 82.5 nm, about 80 nm to about 85 nm, about 82.5 nm to about 87.5 nm, about 85 nm to about 90 nm, about 87.5 nm to about 92.5 nm, about 90 nm to about 95 nm, about 92.5 nm to about 97.5 nm, and about 95 nm to about 99 nm, and combinations thereof.

### Claim 7 (depends on 1)

The composition of claim 1, wherein said cannabinoid micelle has a hydrophobic core of between about five to about fifty molecules of said cannabinoid.

### Claim 8 (depends on 1)

The composition of claim 1, wherein said surfactant is selected from the group consisting of: monoglycerides, diglycerides, polyethylene glycol sorbitan fatty acid esters; polyethylene glycol alkyl ethers, phospholipids, hydrophilic derivatives of phospholipids, PEG-40 castor oil, PEG-60 corn glycerides, vitamin E, TWEEN 80, polyoxyethylene alkyl ethers, polyethylene glycol glycerol fatty acid esters, and polyoxyethylene sorbitan fatty acid esters, or combinations thereof.

### Claim 9 (depends on 1)

The composition of claim 1, further comprising a solvent in which said mixture disperses or dissolves.

### Claim 10 (depends on 1)

The composition of claim 1, further comprising a terpene included in said mixture.

### Claim 11 (depends on 10)

The composition of claim 10, wherein said amount of cannabinoid-cyclodextrin complex comprises an amount of a cannabinoid-terpene-cyclodextrin complex including said cannabinoid and said terpene associated with said β-cyclodextrin.

### Claim 12 (depends on 11)

The composition of claim 11, further comprising a portion of said cannabinoid-cyclodextrin complex associated with a portion of said cannabinoid micelle.

### Claim 13 (depends on 11)

The composition of claim 11, further comprising a portion of said cannabinoid-terpene-cyclodextrin complex associated with a portion of said cannabinoid micelle.