Denaturants for sympathomimetic amine salts

Abstract

The instant invention makes impractical the use of sympathomimetic amine compositions in illicit drug production. More specifically, the preparation of methamphetamine from the disclosed pseudoephedrine hydrochloride formulations is inhibited. The present invention defines pharmaceutical compositions comprising a sympathomimetic amine salt and at least one combination inhibitor, the combination inhibitor which acts both to interfere with the isolation of the sympathomimetic amine from the composition and to interfere with the conversion of the sympathomimetic amine to another pharmacologically active compound. The contemplated compositions may also include reaction and separation inhibitors in any mixture to assure maximum protection against the use of the sympathomimetic amine-containing compositions for illegal drug manufacture. The presence of the combination, reaction and separation inhibitors does not significantly alter the release of the sympathomimetic amine from the composition.

Description

[0001] This application claims priority to U.S. provisional application No. 60 / 099,712, filed Sep. 10, 1998.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to pharmaceutical compositions comprising a sympathomimetic amine salt and at least one combination inhibitor, the combination inhibitor which acts both to interfere with the isolation of the sympathomimetic amine from the composition and to interfere with the conversion of the sympathomimetic amine to another pharmacologically active compound. [0004] 2. Sympathomimetic Amines and the Problem of Unconventional Use [0005] The acid salts of sympathomimetic amines are widely used active agents in over-the-counter (OTC) pharmaceuticals. As their name suggests, this class of compounds produces pharmacological effects which mimic the activation of the sympathetic nervous system. For example, the hydrochloride salt of the sympathomimetic amine pseudoephedrine is a commonly used active in...

AI Technical Summary

Benefits of technology

[0015] The incorporation of at least one combination inhibitor in pharmaceutical compositions of sympathomimetic amines, the subject of this invention, represents a unique discovery in the area of drug formulations involving this class of active agents. The purpose of the combination inhibitor is to prevent the use of OTC sympathomimetic amine pharmaceuticals in the production of illegal drugs, particularly the synthesis of methamphetamine from pseudoephedrine. It achieves this purpose by interfering with both the isolation of the sympathomimetic amine from the composition and the conversion of the sympathomimetic amine to other pharmacologically active compounds. The combination inhibitor is present in an amount sufficient to accomplish the goal without significantly altering the release, bioavailability or dosage of the active ingredient. The advantage of the present invention is that a single component deters both traditional extraction conditions used in illegal drug synthesis as well as alternate, more sophisticated separation techniques.

is that a single component deters both traditional extraction conditions used in illegal drug synthesis as well as alternate, more sophisticated separation techniques.

Problems solved by technology

It achieves this purpose by interfering with both the isolation of the sympathomimetic amine from the composition and the conversion of the sympathomimetic amine to other pharmacologically active compounds.

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