# US 10,500,190 B1 · Sublingual or buccal administration of melatonin and/or valerian

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- Number: US 10,500,190 B1
- Document ID: US10500190B1
- Status: Granted
- Kind: B1
- Application number: 16/389,005
- Filed: 2019-04-19
- Granted: 2019-12-10
- Earliest claimed: 2019-04-19
- Applicants: Michael Farber
- Inventors: Michael Farber
- Web page: https://patentgrep.com/patent/US10500190B1

## CPC

- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
- A61K 9/1271: Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers (liposomes as conjugates {A61K47/6911})
- A61K 36/84: Valerianaceae (Valerian family), e.g. valerian
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61P 25/20: Hypnotics; Sedatives
- A61K 9/0058: {Chewing gums (non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00)}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- 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

A pharmaceutical composition for sublingual or buccal administration of melatonin and valerian is complexed with a beta cyclodextrin or another complexation agent. It is then encased in a liposome. The molecules encased in the liposome are then dehydrated and compounded into any of a number of dosage forms such as a dissolvable strip of material, a gum, lozenge, mint, tablet, or powder.

## Claims

### Claim 1

A compound for use in inducing sleep, comprising:
melatonin in a cyclodextrin compound;
valerian extract in a cyclodextrine compound;
a liposomal construct encapsulating the cyclodextrine complexes through use of a hydrated phospholipid;
an absorption enhancer;
a solvent for said absorption enhancer.

### Claim 2 (depends on 1)

The compound of claim 1, wherein a weight of said melatonin is between 0.05 milligrams and 5 milligrams, inclusive.

### Claim 3 (depends on 2)

The compound of claim 2, wherein a weight of said valerian is between 0.5 milligrams and 25 milligrams, inclusive.

### Claim 4 (depends on 3)

The compound of claim 3, wherein said compound is produced into a water soluble strip.

### Claim 5 (depends on 1)

The compound of claim 1, wherein said absorption enhancer comprises piperin.

### Claim 6 (depends on 5)

The compound of claim 5, wherein said solvent comprises olive oil as a solvent for said piperin.

### Claim 7 (depends on 6)

The compound of claim 6, wherein said compound further comprises a plasticizer.

### Claim 8 (depends on 1)

The compound of claim 1 further comprising at least two of myrcene, linalool, betacaryophyllene, gamma amino butyric acid.

### Claim 9 (depends on 1)

The compound of claim 1, further comprising at least two of tryptophan or a derivative thereof, magnesium salts, chelates, and a sedative.

### Claim 10 (depends on 8)

The compound of claim 8, wherein said compound is designed to be placed sub-lingually or buccally.

### Claim 11 (depends on 10)

The compound of claim 10, wherein said compound is in a dissolvable rectangular strip of material.

### Claim 12 (depends on 1)

The compound of claim 1, wherein said compound is in a gum, lozenge, mint, tablet, or powder form.