Abuse resistant drug formulation

Abstract

A pharmaceutical composition may include a granulate which may include at least one active pharmaceutical ingredient susceptible to abuse by an individual mixed with at least two materials, a first material that is substantially water insoluble and at least partially alcohol soluble and a second material that is substantially alcohol insoluble and at least partially water soluble, wherein the active pharmaceutical ingredient and the two materials are granulated in the presence of water and alcohol. The composition may also include a coating on the granulate exhibiting crush resistance which may have a material that is deposited on the granulate using an alcohol based solvent. The composition further comprises a second particle comprising a fat/wax. The present invention also includes a coated granulate, various dosage forms of the composition, as well as methods of production and tableting.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of the filing date of U.S. Provisional Patent Application Nos. 60 / 845,128 filed Sep. 15, 2006, 60 / 845,127 filed Sep. 15, 2006, 60 / 845,126 filed Sep. 15, 2006, 60 / 845,151 filed Sep. 15, 2006, and 60 / 850,456 filed Oct. 10, 2006, the disclosures of which are hereby incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Some prescription drugs provide a controlled release of the active pharmaceutical ingredient (“API”) that they are intended to deliver. Controlled release can be a delayed release such as an enteric release in the intestines. It can be an extended release where release begins immediately or shortly after ingestion and continues, either at a constant rate or in some pattern, over an extended period of time, usually from about 6 to about 24 hours. Often this is accomplished using a controlled release coating. Not only are controlled release dosage forms, and especially extended rele...

AI Technical Summary

Benefits of technology

[0045]Further aspects of the present invention include methods of making the granulates, particle mixtures and coated particles described herein and of making dosage forms including same, as well as methods of using the coated particles of the invention and dosage forms including same, particularly to reduce drug abuse.

Problems solved by technology

However, with drugs like oxycodone and indeed for many other drugs, this is an impractical and inefficient dosing system.

In addition, there is a risk to the patient in that such high initial API levels can cause significant side effects.

Those who seek to abuse these types of products to “get high” can be frustrated by such extended and indeed other controlled release strategies.

These strategies actively prevent one from obtaining high blood levels of the drug which can cause the euphoria or other physiologic effects which they are actually seeking, but which normal patients would consider an undesirable or even dangerous side effect.

This can cause the rupture or otherwise compromise the API particle and / or controlled release coating, exposing more of the API to digestion and absorption more quickly, allowing the abuser to achieve much higher blood levels.

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