# US 9,517,208 B2 · Abuse-deterrent dosage forms

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- Number: US 9,517,208 B2
- Document ID: US9517208B2
- Status: Granted
- Kind: B2
- Application number: 14/207,826
- Filed: 2014-03-13
- Published: 2014-09-18
- Granted: 2016-12-13
- Earliest claimed: 2013-03-15
- Assignees: Purdue Pharma L.P.
- Applicants: Purdue Pharma L.P.
- Inventors: Debora L Guido; Haiyong Huang
- Web page: https://patentgrep.com/patent/US9517208B2

## CPC

- A61K 9/28: Dragees; Coated pills or tablets {, e.g. with film or compression coating (A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209)}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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

Abuse-deterrent dosage forms (e.g., orally administered dosage forms, transdermal dosage forms, suppositories, etc.), processes for formulating pharmaceutical dosage forms comprising an active agent susceptible to abuse (e.g., an opioid agonist, a benzodiazepine, a stimulant) such that the resulting dosage forms are abuse-deterrent are described. Also described are methods of deterring abuse of pharmaceutical dosage forms.

## Claims

### Claim 1

An abuse-deterrent dosage form comprising an active agent susceptible to abuse and a tonicity-increasing agent, wherein
the tonicity-increasing agent is in an effective amount to provide a hypertonic solution, suspension or gel comprising the active agent upon contact of the dosage form with from 2 ml to 5 ml of a solvent,
the hypertonic solution, suspension or gel has an osmotic pressure of from about 380 mOsmol/L to about 10000 mOsmol/L, a viscosity of less than about 8 cP and is sufficiently hypertonic to deter abuse,
the abuse-deterrent dosage form is an abuse-deterrent transdermal dosage form,
the active agent susceptible to abuse is an opioid agonist,
the solvent comprises water, saliva and/or nasal secretions, and
the tonicity-increasing agent is the only abuse-deterrent agent in the dosage form.

### Claim 2 (depends on 1)

The dosage form of claim 1, wherein the tonicity-increasing agent is sequestered in one or more particles.

### Claim 3 (depends on 2)

The dosage form of claim 2, wherein at least one of said particles comprises the tonicity-increasing agent dispersed in a hydrophobic material.

### Claim 4 (depends on 2)

The dosage form of claim 2, wherein at least one of said particles comprises the tonicity-increasing agent coated with a hydrophobic material.

### Claim 5 (depends on 2)

The dosage form of claim 2, wherein at least one of said particles comprises the tonicity-increasing agent dispersed in a first hydrophobic material and coated with a second hydrophobic material, and the hydrophobic materials are independently selected from the group consisting of (i) an alkylcellulose; (ii) an acrylic polymer; or (iii) mixtures thereof.

### Claim 6 (depends on 1)

The dosage form of claim 1, which releases the active agent at a controlled release rate for a time period of from about 30 minutes to about 30 hours.

### Claim 7 (depends on 1)

The dosage form of claim 1, wherein the dosage form releases at least 50% of the active agent and the tonicity-increasing agent within 30 minutes of placement of the dosage form in 900 ml of water.

### Claim 8 (depends on 1)

The dosage form of claim 1, wherein the opioid agonist is selected from the group consisting of oxycodone, hydrocodone, hydromorphone, morphine and salts of any of the foregoing.