# US 9,931,303 B1 · Abuse deterrent formulations of amphetamine

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- Number: US 9,931,303 B1
- Document ID: US9931303B1
- Status: Granted
- Kind: B1
- Application number: 15/591,677
- Filed: 2017-05-10
- Granted: 2018-04-03
- Earliest claimed: 2017-02-06
- Assignees: Alcobra Ltd.
- Applicants: Alcobra Ltd.
- Inventors: Yaron Daniely; David Baker; Hanna Ron; David Siner
- Web page: https://patentgrep.com/patent/US9931303B1

## CPC

- A61K 9/4866: {Organic macromolecular compounds}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 25/36: Opioid-abuse
- 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

The present invention relates generally to abuse-deterrent formulations containing dextroamphetamine sulfate.

## Claims

### Claim 1

An abuse-deterrent formulation, comprising medicament, poloxamer, water-soluble anionic polysaccharide, and PEG ester;
wherein the medicament is
or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the poloxamer is poloxamer 124.

### Claim 3 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the water-soluble anionic polysaccharide is gellan gum.

### Claim 4 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the PEG ester is polyoxyl stearate.

### Claim 5 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the ratio of poloxamer:water-soluble anionic polysaccharide:PEG ester is about 40:30:30.

### Claim 6 (depends on 1)

The abuse-deterrent formulation of claim 1, comprising 33-43 wt % of poloxamer; 24-32 wt % of water-soluble anionic polysaccharide; and 24-32 wt % of PEG ester.

### Claim 7 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the poloxamer is poloxamer 124, the water-soluble anionic polysaccharide is gellan gum, and the PEG ester is polyoxyl stearate.

### Claim 8 (depends on 7)

The abuse-deterrent formulation of claim 7, wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30.

### Claim 9 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the poloxamer is Kollisolv P124, the water-soluble anionic polysaccharide is Kelcogel CGHA, and the PEG ester is Gelucire 48/16.

### Claim 10 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the medicament is the S enantiomer, or a pharmaceutically acceptable salt thereof.

### Claim 11 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the medicament is dextroamphetamine, or a pharmaceutically acceptable salt thereof.

### Claim 12 (depends on 1)

The abuse-deterrent formulation of claim 1, wherein the medicament is a sulfate salt.

### Claim 13 (depends on 1)

The abuse-deterrent formulation of claim 1, further comprising a capsule.

### Claim 14 (depends on 1)

The abuse-deterrent formulation of claim 1, comprising about 10 mg to about 50 mg of medicament.

### Claim 15

An abuse-deterrent formulation, comprising medicament, poloxamer 124, gellan gum, and polyoxyl stearate;
wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30;
the medicament is
or a pharmaceutically acceptable salt thereof; and
wherein at least 80% of the medicament is released in solution within 45 minutes.

### Claim 16 (depends on 15)

The abuse-deterrent formulation of claim 15, wherein the medicament is the S enantiomer, or a pharmaceutically acceptable salt thereof.

### Claim 17 (depends on 15)

The abuse-deterrent formulation of claim 15, wherein the medicament is dextroamphetamine, or a pharmaceutically acceptable salt thereof.

### Claim 18 (depends on 15)

The abuse-deterrent formulation of claim 15, wherein the medicament is a sulfate salt.

### Claim 19 (depends on 15)

The abuse-deterrent formulation of claim 15, comprising about 10 mg to about 50 mg of medicament.

### Claim 20 (depends on 15)

The abuse-deterrent formulation of claim 15, wherein the poloxamer 124 is Kollisolv P124, the gellan gum is Kelcogel CGHA, and the polyoxyl stearate is Gelucire 48/16.