Disulfiram and metal salt staggered oral dosing regimen and staggered-release oral unit dosage forms

Abstract

This application relates to methods and compositions for the administration of disulfiram (DSF) and heavy metals zinc and copper for the treatment and prevention of medical conditions, such as cancer. DSF and copper as well as DSF and zinc form active complexes that have been shown to be effective in the treatment of cancers. However, as described herein, DSF is incompatible with either copper or zinc for simultaneous oral administration. Included herein are improved methods and oral dosage forms comprising DSF and copper and DSF and zinc in fixed dose combinations that are configured to temporally stagger release of either DSF and copper or DSF and zinc after ingestion.

What is claimed is: 
     
         1 . A method of administering copper and disulfiram on a staggered oral dosing regimen, the method comprising:
 administering an immediate release disulfiram dosage form with a delayed release copper dosage form.   
     
     
         2 . The method of  claim 1 , wherein the copper is formulated to be released greater than 30 minutes after the release of disulfiram. 
     
     
         3 . The method of  claim 2 , wherein the copper is in the form of copper gluconate or copper glycinate. 
     
     
         4 . The method of  claim 3 , wherein the copper is coated with an enteric coating or a gastro-resistant coating.