Pharmaceutical Composition

Abstract

Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided. Methods for treating pain using such compositions is also demonstrated.

What is claimed is: 
     
         1 . A method of treating a condition in a host that is responsive to an agonist, the method comprising administering a multi-layer pharmaceutical composition comprising an agonist and an antagonist thereof that are not in direct contact with one another in the intact form of the composition, wherein administration of the intact form of the composition to the host once or twice daily for at least one week results in zero release of the antagonist. 
     
     
         2 . The method of  claim 1  wherein administration of the intact form of the composition to the host once daily for at least a time period selected from the group consisting of four, eight, 12, 16, 20, 24, 28, 32, 36, 40 and 100 weeks results in zero release of antagonist. 
     
     
         3 . The method of either  claim 1  or  2  wherein the antagonist is naltrexone. 
     
     
         4 . The method of either  claim 3  wherein release of naltrexone is determined by measuring plasma levels of β-naltrexol. 
     
     
         5 . A method of treating a condition in a host that is responsive to an agonist, the method comprising administering a multi-layer pharmaceutical composition comprising an agonist and an antagonist thereof that are not in direct contact with one another in the intact form of the composition, wherein administration of the intact form of the composition to a population once daily for a time period of at least one week results in zero release of the antagonist in about 90% of the population. 
     
     
         6 . The method of  claim 1  wherein the time period is selected from the group consisting of four, eight, 12, 16, 20, 24, 28, 32, 36, 40 and 100 weeks results in zero release of antagonist. 
     
     
         7 . The method of either  claim 1  or  2  wherein the antagonist is naltrexone. 
     
     
         8 . The method of either  claim 3  wherein release of naltrexone is determined by measuring plasma levels of β-naltrexol. 
     
     
         9 . A method of treating a condition in a host that is responsive to an agonist, the method comprising administering a multi-layer pharmaceutical composition comprising an agonist and an antagonist thereof that are not in direct contact with one another in the intact form of the composition, wherein administration of the intact form of the composition to the host once or twice daily for a time period of at least two weeks provides an analgesic effect. 
     
     
         10 . The method of  claim 9  wherein the time period is selected from the group consisting of four, eight, 12, 16, 20, 24, 28, 32, 36, 40 and 100 weeks.