Abuse-resistant oral dosage forms and method of use thereof

Abstract

An opioid-antagonist oral dosage form which does not release a therapeutically effective amount of the opioid antagonist when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the therapeutically effective amount of the opioid antagonist. An embodiment of the oral dosage form includes an opioid-antagonist layer coated onto a biologically inert pellet, and a non-releasing membrane coated onto the opioid-antagonist layer. Optionally, the oral dosage form can also include an opioid agonist, such that a method of preventing the abuse of an oral dosage form of an opioid agonist is provided by forming the oral dosage form including an opioid agonist and an opioid antagonist.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application is a continuation of prior co-pending U.S. application Ser. No. 10 / 409,992, filed Apr. 8, 2003, the entire disclosure of which is hereby incorporated by reference.FIELD OF THE INVENTION[0002]The invention relates to an abusive-resistant substance, such as an opioid-antagonist, oral dosage form which does not release the opioid antagonist in a therapeutically effective amount when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the opioid antagonist in an amount effective to prevent the abuse. The oral dosage form can further include an abusable substance, such as an opioid agonist, in order to prevent the abuse of the opioid agonist. A preferred embodiment of the invention includes naltrexone as the abuse-resistant substance in an oral dosage form.BACKGROUND OF THE INVENTION[0003]Opioid agonists, or opioids, are drugs wh...

AI Technical Summary

Benefits of technology

[0010]An embodiment of the present invention is directed to an opioid-antagonist oral dosage form wherein the opioid antagonist does not release unless the oral dosage form is crushed or ground up, thereby antagonizing the opioid effect of an opioid agonist.

Problems solved by technology

Although they are effective in reducing the perceived pain by a patient, opioid agonists also have the characteristic of possibly being physically and psychologically addictive to the patient if used repeatedly over an extended period of time.

Thus, the potential for addiction to or abuse of such drugs is an issue of concern whenever prescribing such drugs as analgesics.

For example, oxycodone is an opioid agonist which has a high potential for abuse.

Thus, in this way the abuser is able to receive a relatively large single dose of the oxycodone, resulting in a euphoric “high” being experienced by the abuser.

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