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.

1 - 31 . (canceled)  
     
     
         32 . A pharmaceutical composition comprising: 
 an acid salt of a sympathomimetic amine; and    at least one combination inhibitor, said combination inhibitor being an amino polymer or a salt of a transition metal selected from the group consisting of iron, cobalt, copper, manganese, nickel and zinc,    wherein each said combination inhibitor is a single component and is present in amounts sufficient to interfere with the isolation of said sympathomimetic amine and to interfere with the conversion of said sympathomimetic amine to other pharmacologically active compounds without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.    
     
     
         33 . The composition according to  claim 32 , wherein said transition metal salt is present in an amount from about 0.1 mg to about 25 mg.  
     
     
         34 . The composition according to  claim 32 , wherein said transition metal salt is present in an amount from about 0.25 mg to about 15 mg.  
     
     
         35 . The composition according to  claim 32 , wherein said transition metal salt is present in an amount from about 0.5 mg to about 10 mg.  
     
     
         36 . The composition according to  claim 32 , wherein said composition comprises an amino polymer, an iron salt, a copper salt and a zinc salt.  
     
     
         37 . The composition according to  claim 32 , wherein said amino polymer is present in an amount from about 10 mg to about 100 mg.  
     
     
         38 . The composition according to  claim 32 , wherein said amino polymer is present in an amount from about 20 mg to about 50 mg.  
     
     
         39 . The composition according to  claim 32 , wherein said amino polymer is present in an amount from about 30 mg to about 40 mg.  
     
     
         40 . The composition according to  claim 32  further comprising at least one reaction inhibitor, wherein said reaction inhibitor is present in amounts sufficient to interfere with the conversion of said sympathomimetic amine to other pharmacologically active compounds without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.  
     
     
         41 . The composition according to  claim 32  further comprising at least one separation inhibitor, wherein said separation inhibitor is present in amounts sufficient to interfere with the isolation of said sympathomimetic amine without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.  
     
     
         42 . The composition according to  claim 40  further comprising at least one separation inhibitor, wherein said separation inhibitor is present in amounts sufficient to interfere with the isolation of said sympathomimetic amine without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.  
     
     
         43 . The composition according to  claim 32  wherein said sympathomimetic amine is selected from the group consisting of pseudoephedrine, pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine and pharmaceutically acceptable salts thereof.  
     
     
         44 . The composition according to  claim 32  wherein said sympathomimetic amine is pseudoephedrine or a pharmaceutically acceptable salt thereof.  
     
     
         45 . The composition according to  claim 32  wherein said sympathomimetic amine is phenylephrine or pharmaceutically acceptable salt thereof.  
     
     
         46 . The composition of  claim 32  wherein said composition is in the form selected from the group consisting of a tablet, capsule, granule, powder, lozenge and liquid.  
     
     
         47 . A pharmaceutical composition comprising: 
 an acid salt of a sympathomimetic amine; and    a combination inhibitor, said combination inhibitor comprises at least one amino polymer and at least one salt of a transition metal selected from the group consisting of iron, cobalt, copper, manganese, nickel and zinc,    wherein each said combination inhibitor is a single component and is present in amounts sufficient to interfere with the isolation of said sympathomimetic amine and to interfere with the conversion of said sympathomimetic amine to other pharmacologically active compounds without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.    
     
     
         48 . The pharmaceutical composition according to  claim 47  further comprising at least one reaction inhibitor, wherein said reaction inhibitor is present in amounts sufficient to interfere with the conversion of said sympathomimetic amine to other pharmacologically active compounds without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.  
     
     
         49 . The pharmaceutical composition according to  claim 47  further comprising at least one separation inhibitor, wherein said separation inhibitor is present in amounts sufficient to interfere with the isolation of said sympathomimetic amine without significantly altering the release of said sympathomimetic amine from said pharmaceutical composition as compared to the undenatured composition.  
     
     
         50 . The pharmaceutical composition according to  claim 47  wherein said sympathomimetic amine is pseudoephedrine hydrochloride.  
     
     
         51 . The pharmaceutical composition according to  claim 47  wherein said sympathomimetic amine is phenylephrine hydrochloride.