# US 11,026,896 B2 · Transdermal penetrant formulations containing cannabidiol

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- Number: US 11,026,896 B2
- Document ID: US11026896B2
- Status: Granted
- Kind: B2
- Application number: 16/546,270
- Filed: 2019-08-20
- Published: 2020-12-24
- Granted: 2021-06-08
- Earliest claimed: 2019-06-18
- Assignees: Dyve Biosciences, Inc.
- Applicants: Ampersand Biopharmaceuticals, Inc.
- Inventors: Nathan Fitzsimmons; Ryan Beal; Audrene McMahon; Brandon Sand; Kilmar Martinez
- Web page: https://patentgrep.com/patent/US11026896B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 31/4152: having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
- A61K 31/426: 1,3-Thiazoles
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- 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 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 35/00: Antineoplastic agents
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed herein is a transdermal delivery formulation for transdermal delivery of a Cannabidiol, with or without one or more additional active agents through the dermis, including the skin, nail or hair follicle of a subject, wherein the formulation comprises a) a transdermal delivery formulation in an amount less than about 60% w/w, comprising i. one or more phosphatides, ii. glucose, and iii. one or more fatty acids; b) water in an amount less than about 50% w/w, a Cannabidiol with or within one or more additional active agents.

## Claims

### Claim 1

A method of treating a patient with an ailment by applying a transdermal formulation to the skin of the patient, the transdermal formulation comprising the following components:
a. Cannabidiol at a concentration from 1% to 7%;
b. a phosphatidylcholine at a concentration from 4% to 15%;
c. glucose at a concentration from 0% to 3%;
d. benzyl alcohol at a concentration from 0.25% to 5%;
e. deionized water at a concentration from 10% to 75%;
f. safflower oil at a concentration from 1% to 20%;
g. oleic acid at a concentration from 0.2% to 7.5%;
h. stearic acid at a concentration from 0.1% to 7%; and
i. isopropyl palmitate at a concentration from 5% to 30%,
wherein the ailment is pain, seizures or Parkinson's disease and wherein all amounts are percent by weight relative to the total weight of said transdermal formulation (w/w).

### Claim 2 (depends on 1)

The method of claim 1, wherein the Cannabidiol is at a concentration from 1.5% to 6%.

### Claim 3 (depends on 1)

The method of claim 1, wherein the transdermal formulation further comprises one or more of a moisturizer, cream, oil or lotion.

### Claim 4 (depends on 1)

The method of claim 1, wherein the transdermal formulation further comprises a surfactant.

### Claim 5 (depends on 1)

The method of claim 1, wherein the transdermal formulation further comprises a nonionic detergent.

### Claim 6 (depends on 1)

The method of claim 1, wherein the transdermal further comprises a polar gelling agent.

### Claim 7 (depends on 1)

The method of claim 1, wherein the transdermal formulation further comprises an antioxidant.

### Claim 8 (depends on 1)

The method of claim 1, wherein the transdermal formulation further comprises one or more additional active agents to treat the pain, seizures or Parkinson's disease.

### Claim 9 (depends on 1)

The method of claim 1, wherein the transdermal formulation has a pH from 4-6.

### Claim 10 (depends on 1)

The method of claim 1, wherein the safflower oil comprises a linoleic acid.