Transdermal dosage form

Abstract

The disclosure generally relates to tamper-resistant transdermal dosage forms. The dosage forms can comprise an active agent and more than one antagonist reservoir.

What is claimed is: 
     
         1 . A transdermal dosage system for administering fentanyl to a human comprising fentanyl, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof,
 wherein the ratio of naltrexone, or a pharmaceutically acceptable salt thereof, to fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the system, after between 5 minutes and 4 hours of tampering by immersion or substantial immersion of the system in a solvent that is an aqueous solvent, is at least 1:1; and,   wherein the ratio of naltrexone, or a pharmaceutically acceptable salt thereof, to fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the system, after between 5 minutes and 4 hours of tampering by immersion or substantial immersion of the system in a solvent that is an organic solvent, is at least 1:1.   
     
     
         2 . The transdermal dosage system of  claim 1 , wherein the solvent is water. 
     
     
         3 . The transdermal system of  claim 2 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature is at least 3.4:1 after 10 minutes of tampering. 
     
     
         4 . The transdermal system of  claim 2 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. is at least 4.8:1 after 10 minutes of tampering. 
     
     
         5 . The transdermal system of  claim 2 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. is at least 6.6:1 after 30 minutes of tampering. 
     
     
         6 . The transdermal system of  claim 2 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature is at least 3.6:1 after 30 minutes of tampering. 
     
     
         7 . The transdermal dosage system of  claim 1 , wherein the solvent is cooking vinegar. 
     
     
         8 . The transdermal system of  claim 7 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature is at least 5.4:1 after 10 minutes of tampering. 
     
     
         9 . The transdermal system of  claim 7 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. is at least 4.6:1 after 10 minutes of tampering. 
     
     
         10 . The transdermal system of  claim 7 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. is at least 4.9:1 after 30 minutes of tampering. 
     
     
         11 . The transdermal system of  claim 7 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature is at least 5.2:1 after 30 minutes of tampering. 
     
     
         12 . The transdermal dosage system of  claim 1 , wherein the solvent is ethanol. 
     
     
         13 . The transdermal system of  claim 12 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature is at least 5.9:1 after 10 minutes of tampering. 
     
     
         14 . The transdermal system of  claim 12 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. is at least 5.9:1 after 10 minutes of tampering. 
     
     
         15 . The transdermal system of  claim 12 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. is at least 6.0:1 after 30 minutes of tampering. 
     
     
         16 . The transdermal system of  claim 12 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature is at least 6.0:1 after 30 minutes of tampering. 
     
     
         17 . The transdermal dosage system of  claim 1 , wherein the solvent is pH 6.8 phosphate buffer. 
     
     
         18 . The transdermal dosage system of  claim 1 , wherein the solvent is artificial saliva. 
     
     
         19 . The transdermal dosage system of  claim 1 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or the pharmaceutically acceptable salt thereof, extracted from the dosage system by water, ethanol, pH 6.8 phosphate buffer, cooking vinegar, or artificial saliva, is at least 1:1 after between 5 minutes and 4 hours of tampering. 
     
     
         20 . The transdermal dosage system of  claim 1 , wherein the tampering occurs at room temperature. 
     
     
         21 . The transdermal dosage system of  claim 1 , wherein the tampering occurs at 70° C. 
     
     
         22 . The transdermal dosage system of  claim 1 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature after 10 minutes of tampering is at least 3.4:1 when the solvent is water and at least 5.9:1 when the solvent is ethanol. 
     
     
         23 . The transdermal dosage system of  claim 1 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. after 10 minutes of tampering is at least 4.8:1 when the solvent is water and at least 5.9:1 when the solvent is ethanol. 
     
     
         24 . The transdermal dosage system of  claim 1 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at room temperature after 30 minutes of tampering is at least 3.6:1 when the solvent is water and at least 6.0:1 when the solvent is ethanol. 
     
     
         25 . The transdermal dosage system of  claim 1 , wherein the ratio of the naltrexone, or a pharmaceutically acceptable salt thereof, to the fentanyl, or a pharmaceutically acceptable salt thereof, extracted from the dosage form at 70° C. after 30 minutes of tampering is at least 6.6:1 when the solvent is water and at least 6.0:1 when the solvent is ethanol.