Tamper-resistant tablet providing immediate drug release

Abstract

The invention relates to a tamper-resistant tablet comprising

• • (i) a matrix material in an amount of more than one third of the total weight of the tablet; and
  • (ii) a plurality of particulates in an amount of less than two thirds of the total weight of the tablet; wherein said particulates comprise a pharmacologically active compound and a polyalkylene oxide; and form a discontinuous phase within the matrix material;

and method of using said tablet to treat pain and other conditions.

Description

PRIORITY[0001]This application claims priority of U.S. Provisional Patent Application No. 61 / 512,939, filed on Jul. 29, 2011, and European Patent Application No. 11 006 253.6, filed on Jul. 29, 2011, the contents of both of which patent applications are incorporated herein by reference.FIELD OF THE INVENTION[0002]The invention relates to tamper-resistant tablets comprising a matrix material and a plurality of particulates which comprise a pharmacologically active compound and form a discontinuous phase within the matrix material.BACKGROUND OF THE INVENTION[0003]A large number of pharmacologically active substances have a potential for being abused or misused, i.e. they can be used to produce effects which are not consistent with their intended use. Thus, e.g. opioids which exhibit an excellent efficacy in controlling severe to extremely severe pain, are frequently abused to induce euphoric states similar to being intoxicated. In particular, active substances which have a psychotropi...

AI Technical Summary

Benefits of technology

[0021]It has been surprisingly found that the in vitro release profile of tamper-resistant dosage forms can be accelerated by embedding particulates containing the pharmacologically active compound in a matrix material and increasing the relative weight ratio of the matrix material to the particulates.

[0022]Further, it has been surprisingly found that mixtures of matrix material, optionally in pre-compacted or pre-granulated form, can be

Problems solved by technology

A large number of pharmacologically active substances have a potential for being abused or misused, i.e. they can be used to produce effects which are not consistent with their intended use.

However, the presence of such aversive agents is principally not desirable and there is a need to provide sufficient tamper-resistance without relying on aversive agents and/or antagonists.

Such pharmaceutical dosage forms are useful for avoiding drug abuse of the pharmacologically active compound contained therein, as they may not be powdered by conventional means and thus, cannot be administered in powdered form, e.g. nasally.

The p

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