Transdermal delivery systems

Abstract

Transdermal delivery systems for administering sufentanil through the skin are provided. The systems contain a sufficient amount of sufentanil to induce and maintain a constant state of analgesia when applied to a subject. The systems are characterized as having one or more features including a high degree of dosage form rate control over flux of sufentanil from the system, a high net flux of sufentanil from the system through the skin, lack of a permeation enhancer, an adhesive member demonstrating superior shear time, a low coefficient of variation in the net flux of sufentanil from the system, a high delivery efficiency, and a substantially constant steady state net flux of sufentanil from the system. Methods of using the transdermal delivery systems to administer a sufficient amount of sufentanil to induce and maintain analgesia for extended periods when applied to a subject are also provided.

1 .- 112 . (canceled) 
     
     
         113 . An adhesive system, comprising:
 a backing layer;   a pressure-sensitive adhesive layer; and   a release liner,   wherein the pressure-sensitive adhesive layer comprises:
 a high molecular weight polyisobutylene having a viscosity average molecular weight of 450,000 to 2,100,000, 
 a low molecular weight polyisobutylene having a viscosity average molecular weight of 1,000 to 450,000, 
 plasticizer, and 
 sucrose acetate isobutyrate. 
   
     
     
         114 . The system of  claim 113 , wherein the system does not comprise a rate controlling membrane. 
     
     
         115 . The system of  claim 113 , wherein the system does not contain a permeation enhancer. 
     
     
         116 . The system of  claim 113 , wherein the high molecular weight polyisobutylene and low molecular weight polyisobutylene are present at a ratio ranging from about 20:80 to about 70:30. 
     
     
         117 . The system of  claim 113 , wherein the high molecular weight polyisobutylene and low molecular weight polyisobutylene are present at a ratio ranging from about 40:60 to about 50:50. 
     
     
         118 . The system of  claim 113 , wherein the high molecular weight polyisobutylene has a viscosity average molecular weight of about 1,100,000. 
     
     
         119 . The system of  claim 113 , wherein the low molecular weight polyisobutylene has a viscosity average molecular weight of about 50,000 to 55,000. 
     
     
         120 . The system of  claim 113 , wherein the plasticizer comprises polybutene. 
     
     
         121 . The system of  claim 113 , wherein the pressure-sensitive adhesive layer comprises a reservoir having a dry, non-hydrated thickness of about 1.25 to 5 mils. 
     
     
         122 . The system of  claim 113 , wherein the pressure-sensitive adhesive layer is monolithic. 
     
     
         123 . The system of  claim 113 , wherein the system has a shear time ranging from about 1 to 40 minutes as determined using Shear Time Measurement Test. 
     
     
         124 . The system of  claim 113 , wherein the backing layer comprises a breathable material. 
     
     
         125 . The system of  claim 113 , wherein the backing layer comprises a polymeric material. 
     
     
         126 . The system of  claim 113 , wherein the backing layer comprises a polyester. 
     
     
         127 . The system of  claim 113 , wherein the system does not comprise a rate controlling membrane, and wherein the system does not contain a permeation enhancer. 
     
     
         128 . The system of  claim 113 , wherein the high molecular weight polyisobutylene and low molecular weight polyisobutylene are present at a ratio ranging from about 20:80 to about 70:30, and the high molecular weight polyisobutylene has a viscosity average molecular weight of about 1,100,000. 
     
     
         129 . The system of  claim 113 , wherein the high molecular weight polyisobutylene and low molecular weight polyisobutylene are present at a ratio ranging from about 20:80 to about 70:30, and the low molecular weight polyisobutylene has a viscosity average molecular weight of about 50,000 to 55,000. 
     
     
         130 . The system of  claim 113 , wherein the plasticizer comprises polybutene, and the pressure-sensitive adhesive layer comprises a reservoir having a dry, non-hydrated thickness of about 1.25 to 5 mils. 
     
     
         131 . The system of  claim 113 , wherein the plasticizer comprises polybutene, and the pressure-sensitive adhesive layer is monolithic. 
     
     
         132 . The system of  claim 113 , wherein the plasticizer comprises polybutene, and wherein the backing layer comprises a polyester.