Abuse-resistant pharmaceutical compositions

Abstract

An abuse-resistant controlled release pharmaceutical composition comprising a pharmaceutically effective amount of discrete particles of an active capable of abuse, wherein surfaces of said particles are wetted with a water insoluble coating material, and preferably wherein said composition comprises a matrix, in which said particles are distributed, and which renders the abuse-capable compound within the matrix difficult to separate from the matrix; and a method for the preparation of a controlled release pharmaceutical composition having a reduced potential for abuse, comprising applying a pressure force to a mixture comprising a water insoluble material, and particles of a pharmaceutically active compound capable of inducing in a subject a reaction that is physiologically or psychologically detrimental if administered in an immediate release dosage form, thereby resulting in surface coated particles, and incorporating said surface coated particles into a pharmaceutical composition

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]Applicants claim the benefit of PCT Application No. PCT / US03 / 29890 filed Sep. 23, 2003 which claims the benefit of provisional Application Nos. 60 / 412,861, filed Sep. 23, 2002, and 60 / 413,495, filed Sep. 25, 2002, which are incorporated herein in therein entirety.FIELD OF THE INVENTION[0002]This invention relates to dosage forms of abusable substances having reduced potential for abuse. In particular, the dosage forms of this invention are intended to administer the abusable substance to the body by oral application.[0003]The potential for abuse by either oral or parenteral routes of narcotic and other psychoactive drugs is well known. For example, the potential for abuse of the synthetic narcotic drug fentanyl is so high that it has become a major cause of death for anesthesiologists and other hospital workers having access to the drug. Another well-known mode of abuse is the crushing of extended release dosage forms to convert the exten...

AI Technical Summary

Benefits of technology

This patent relates to a controlled release pharmaceutical composition that is resistant to abuse. The composition includes discrete particles of a compound that can be abused, which have their surfaces coated with a water-insoluble material. The coated particles are distributed throughout a matrix, making it difficult to separate the compound and render it abusable. The composition is designed to release the compound over time in a controlled and safe manner. The use of the tamper-resistant composition reduces the potential for abuse of the compound, as it can be difficult to defeat the modified-release properties of the dosage form. The method for preparing the composition involves applying a pressure force to a mixture of a water-insoluble material and particles of the pharmaceutically active compound. The resulting mixture includes surface-coated particles, which are incorporated into a pharmaceutical composition.

Problems solved by technology

The tamper-resistance of the composition matrix renders the composition difficult to alter and the abuse-potential compound, such as an opiate, contained within the matrix difficult to separate from the matrix.

The use of the tamper-resistant composition renders the modified-release properties of the dosage form difficult to defeat as is commonly done in connection with drug abuse.