# US 2019/0167597 A1 · Tamper Resistant Pharmaceutical Formulations

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- Number: US 2019/0167597 A1
- Document ID: US20190167597A1
- Status: Published application
- Kind: A1
- Application number: 16/234,732
- Filed: 2018-12-28
- Published: 2019-06-06
- Earliest claimed: 2013-03-15
- Assignees: Purdue Pharma L.P.
- Applicants: Purdue Pharma L.P.
- Inventors: Rama Abu Shmeis; Sheetal R. Muley; Xiaohong Shen; Zhixin Zong
- Web page: https://patentgrep.com/patent/US20190167597A1

## CPC

- A61K 9/2081: {with microcapsules or coated microparticles according to A61K9/50}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- 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 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2095: {Tabletting processes}
- A61K 9/2846: {Poly(meth)acrylates}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 9/501: {Inorganic compounds}
- A61K 9/5015: {Organic compounds, e.g. fats, sugars}
- A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/5047: {Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose}
- A61K 9/5073: {having two or more different coatings optionally including drug-containing subcoatings}
- A61K 9/5084: {Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs (tablets containing such a mixture A61K9/2077)}
- A61K 9/5089: {Processes}
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- 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

Disclosed in certain embodiments is a solid oral dosage form comprising a plurality of particles, each particle comprising (i) a core comprising an active agent susceptible to abuse and an internal adhesion promoter, wherein the cores are (i) dispersed in a matrix comprising a controlled release material or (ii) coated with a controlled release material. The dosage form can also include an alcohol resistant material.

## Claims

### Claim 1

A solid oral dosage form comprising a plurality of particles, each particle comprising a core comprising an active agent susceptible to abuse and an internal adhesion promoter, wherein the cores are (i) dispersed in a matrix comprising a controlled release material or (ii) coated with a controlled release material.

### Claim 2 (depends on 1)

The solid oral dosage form of claim 1, wherein the core further comprises a dissolution enhancer.

### Claim 3 (depends on 1)

The solid oral dosage form of claim 1, wherein the coating or matrix further comprises a pore former.

### Claim 4 (depends on 1)

The solid oral dosage form of claim 1, further comprising an alcohol resistant material.

### Claim 5 (depends on 4)

The solid oral dosage form of claim 4, further comprising an external adhesion promoter to promote the adhesion of the alcohol resistant material and the controlled release material.

### Claim 6 (depends on 1)

The solid oral dosage form of claim 1, wherein the controlled release material is a polymer.

### Claim 7 (depends on 1)

The solid oral dosage form of claim 1, wherein the controlled release material is an acrylic polymer.

### Claim 8 (depends on 1)

The solid oral dosage form of claim 1, wherein controlled release material is a neutral acrylic polymer.

### Claim 9 (depends on 1)

The solid oral dosage form of claim 1, wherein the internal adhesion promoter is selected from the group consisting of a cellulosic material, a surfactant, a carbomer and a mixture thereof.

### Claim 10 (depends on 9)

The solid oral dosage form of claim 9, wherein the cellulosic material is hydroxypropylmethylcellulose.

### Claim 11 (depends on 9)

The solid oral dosage form of claim 9, wherein the surfactant is a non-ionic surfactant.

### Claim 12 (depends on 11)

The solid oral dosage form of claim 11, wherein the non-ionic surfactant is selected from the group consisting of a nonoxynol, a sorbitan ester and a mixture thereof.

### Claim 13 (depends on 9)

The solid oral dosage form of claim 9, wherein the internal adhesion promoter is a carbomer.

### Claim 14 (depends on 2)

The solid oral dosage form of claim 2, wherein the dissolution enhancer is a cellulosic material, a sugar, a starch or a polymer.

### Claim 15 (depends on 2)

The solid oral dosage form of claim 2, wherein the dissolution enhancer is an alkylycellulose.

### Claim 16 (depends on 2)

The solid oral dosage form of claim 2, wherein the dissolution enhancer is methylcellulose.

### Claim 17 (depends on 3)

The solid oral dosage form of claim 3, wherein the pore former is a polysaccharide, a polymer, an organic solvent or an inorganic material.

### Claim 18 (depends on 3)

The solid oral dosage form of claim 3, wherein the pore former is selected from the group consisting of sodium chloride, lactose, dextrose, mannitol, microcrystalline cellulose, methylcellulose and a mixture thereof.

### Claim 19 (depends on 4)

The solid oral dosage form of claim 4, wherein the alcohol resistant material is a cellulosic material.

### Claim 20 (depends on 4)

The solid oral dosage form of claim 4, wherein the alcohol resistant material is an alkylcellulose.

### Claim at position 21

21-100. (canceled)