# US 10,478,504 B2 · Tamper resistant pharmaceutical formulations

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,478,504 B2
- Document ID: US10478504B2
- Status: Granted
- Kind: B2
- Application number: 15/588,066
- Filed: 2017-05-05
- Published: 2017-10-19
- Granted: 2019-11-19
- Earliest claimed: 2013-02-05
- Assignees: Purdue Pharma L.P.
- Applicants: Purdue Pharma L.P.
- Inventors: Debora Guido; Haiyong Hugh Huang
- Web page: https://patentgrep.com/patent/US10478504B2

## CPC

- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers}
- A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin}
- A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 47/02: Inorganic compounds
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/36: Opioid-abuse
- A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer}
- A61K 31/5375: 1,4-Oxazines, e.g. morpholine
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 31/717: Celluloses
- A61K 31/74: Synthetic polymeric materials
- A61K 31/78: of acrylic acid or 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed in certain embodiments is a solid oral dosage form comprising a heat-labile gelling agent; a thermal stabilizer; and a drug susceptible to abuse.

## Claims

### Claim 1

A solid oral dosage form comprising
a heat-labile gelling agent;
a thermal stabilizer comprising an anionic polymer in a neutral pH aqueous solution; and
a drug susceptible to abuse,
wherein the solid oral dosage form releases at least about 85% of the drug susceptible to abuse within 45 minutes as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at 50 rpm in 500 ml SGF at 37° C.

### Claim 2 (depends on 1)

The solid oral dosage form of claim 1, wherein the polysaccharide is a microbial polysaccharide.

### Claim 3 (depends on 2)

The solid oral dosage form of claim 2, wherein the microbial polysaccharide is xanthan gum.

### Claim 4 (depends on 1)

The solid oral dosage form of claim 1, further comprising a pH-modifying agent.

### Claim 5 (depends on 4)

The solid oral dosage form of claim 4, wherein the pH-modifying agent provides a pH of between about 5.5 and 8.5 to a viscous solution obtained when the dosage form is crushed and mixed with 5 mL of distilled water.

### Claim 6 (depends on 1)

The solid oral dosage form of claim 1, further comprising a disintegrant.

### Claim 7 (depends on 1)

The solid oral dosage form of claim 1, further comprising a filler.

### Claim 8 (depends on 7)

The solid oral dosage form of claim 7, wherein the filler is selected from the group consisting of lactose, dextrose, mannitol, microcrystalline cellulose and a mixture thereof.

### Claim 9 (depends on 1)

The solid oral dosage form of claim 1, comprising the heat-labile gelling agent in an amount from 0.25% to about 75% (w/w) of the dosage form.

### Claim 10 (depends on 1)

The solid oral dosage form of claim 1, comprising the thermal stabilizer in an amount from about 0.25% to about 90% (w/w) of the dosage form.

### Claim 11 (depends on 1)

The solid oral dosage form of claim 1, further comprising an aversive agent.

### Claim 12 (depends on 11)

The solid oral dosage form of claim 11, wherein the aversive agent is a surfactant, capsaicin or a capsaicin analog.

### Claim 13 (depends on 1)

The solid oral dosage form of claim 1, wherein the drug is an opioid agonist.

### Claim 14 (depends on 13)

The solid oral dosage form of claim 13, wherein the opioid agonist is selected from the group consisting of codeine, morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, pharmaceutically acceptable salts thereof, and mixtures thereof.