# US 2014/0155388 A1 · Methods and compositions for self-regulated release of active pharmaceutical ingredient

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- Number: US 2014/0155388 A1
- Document ID: US20140155388A1
- Status: Published application
- Kind: A1
- Application number: 14/091,817
- Filed: 2013-11-27
- Published: 2014-06-05
- Earliest claimed: 2012-11-30
- Assignees: Acura Pharmaceuticals, Inc.
- Applicants: Acura Pharmaceuticals, Inc.
- Inventors: Albert W. BRZECZKO; R. Gary HOLLENBECK
- Web page: https://patentgrep.com/patent/US20140155388A1

## CPC

- A61K 47/02: Inorganic compounds
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2077: {Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets}
- A61K 31/5517: condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
- 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 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/22: Anxiolytics
- A61P 25/26: Psychostimulants, e.g. nicotine, cocaine
- A61P 25/30: for treating abuse or dependence
- A61P 25/36: Opioid-abuse
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

## Claims

### Claim 1

An abuse deterrent pharmaceutical composition comprising:
a. a pharmaceutically active ingredient;
b. an acid soluble ingredient; and
c. a buffering ingredient;
wherein the acid soluble ingredient and the buffering ingredient retard release of the pharmaceutically active ingredient when the composition is ingested in excess of an intended dosage.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the pharmaceutically active ingredient comprises a drug susceptible to abuse.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the pharmaceutically active ingredient comprises a drug with narrow therapeutic index.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the acid soluble ingredient comprises calcium carbonate, cationic copolymer, or combinations thereof.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the acid soluble ingredient comprises a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the pharmaceutically active ingredient is contained within a matrix of the acid soluble ingredient.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the acid soluble ingredient is present in an amount of about 1 wt % to about 40 wt % of the pharmaceutical composition.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the buffering ingredient comprises calcium carbonate, sodium bicarbonate, magnesium oxide, tribasic sodium phosphate, or combinations thereof.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the buffering ingredient is present in an amount of about 45 wt % to about 95 wt %.