Topical patch preparation containing a delayed-type hypersensitivity inducer and methods for using the same

Abstract

Topical patch preparations that contain a delayed-type hypersensitivity inducer, e.g., 1-dichloro-2,4-dinitrobenzene (DNCB), and methods for using the same are provided. The subject topical patch preparations are made up of an adhesive gel composition that is present on a support, where the adhesive gel composition includes the delayed-type hypersensitivity inducer, a water-soluble polymer gel, water and a water holding agent. In using the subject topical patch preparations, the topical patch preparations are applied to a skin surface of a subject and maintained at the site of application for a period of time sufficient for an effective amount of the delayed-type hypersensitivity inducer to be administered to the subject, where this maintenance period typically does not exceed about 60 minutes. The subject invention finds use in a variety of applications where the administration of a delayed-type hypersensitivity inducer is desired, and is particularly suited for use in the treatment of HIV associated disease conditions, e.g., AIDS.

What is claimed is:  
     
         1 . A topical patch preparation of a delayed-type hypersensitivity inducer, said preparation comprising: 
 an adhesive gel composition comprising a delayed-type hypersensitivity inducer; and    a support.    
     
     
         2 . The topical patch preparation according to  claim 1 , wherein said delayed-type hypersensitivity inducer is 1-Chloro-2,4-Dinitrobenzene (DNCB).  
     
     
         3 . The topical patch preparation according to  claim 2 , wherein said DNCB is present in said adhesive gel composition in an amount ranging from about 0.01 to 10.0% (w/w).  
     
     
         4 . The topical patch preparation of  claim 1 , wherein said adhesive gel composition comprises: 
 a water-soluble polymer gel;    water; and    a water retaining agent.    
     
     
         5 . The topical patch preparation according to  claim 4 , wherein said water is present in an amount ranging from about 10 to 80% (w/w).  
     
     
         6 . The topical patch preparation according to  claim 1 , wherein said adhesive gel composition has a pH ranging from about 4.0 to 7.0.  
     
     
         7 . The topical patch preparation according to  claim 1 , wherein said adhesive gel composition further comprises an organic solvent.  
     
     
         8 . The topical patch preparation according to  claim 7 , wherein said organic solvent is selected from the group consisting of n-methyl-2-pyrrolidone, polyethylene glycol and crotamiton and combinations thereof.  
     
     
         9 . A topical patch preparation comprising: 
 (a) an adhesive gel composition having a pH ranging from about 4.0 to 7.0 and comprising: 
 (i) DNCB in an amount ranging from about 0.01 to 10.0% (w/w);  
 (ii) a water-soluble polymer gel;  
 (iii) water in an amount ranging from about 10 to 80% (w/w); and  
 (iv) a water retaining agent; and  
   (b) a support.    
     
     
         10 . The topical patch preparation according to  claim 9 , wherein said DNCB is present in an amount ranging from about 0.1 to 5.0% (w/w).  
     
     
         11 . The topical patch preparation according to  claim 10 , wherein said DNCB is present in an amount ranging from about 0.2 to 3.0% (w/w).  
     
     
         12 . The topical patch preparation according to  claim 9 , wherein said water is present in an amount ranging from about 20 to 70% (w/w).  
     
     
         13 . The topical patch preparation according to  claim 12 , wherein said water is present in an amount ranging from about 30 to 60% (w/w).  
     
     
         14 . The topical patch preparation according to  claim 9 , wherein said pH ranges from about 4.0 to 6.0.  
     
     
         15 . The topical patch preparation according to  claim 14 , wherein said adhesive gel composition further comprises an organic solvent.  
     
     
         16 . The topical patch preparation according to  claim 15 , wherein said organic solvent is selected from the group consisting of n-methyl-2-pyrrolidone, polyethylene glycol, and crotamiton and combinations thereof.  
     
     
         17 . A topical patch preparation comprising: 
 (a) an adhesive gel composition having a pH ranging from about 4.0 to 6.0 and comprising: 
 (i) DNCB in an amount ranging from about 0.2 to 3.0% (w/w);  
 (ii) a water-soluble polymer gel;  
 (iii) water in an amount ranging from about 30 to 60% (w/w);  
 (iv) a water retaining agent; and  
 (v) an organic cosolvent selected from the group consisting of n-methyl-2-pyrrolidone, polyethylene glycol and crotamiton and combinations thereof;  
   (b) a support.    
     
     
         18 . A kit for use in transdermal delivery of a delayed-type hypersensitivity inducer to a subject in need thereof, said kit comprising: 
 (a) a topical patch preparation comprising: 
 (i) an adhesive gel composition comprising an effective amount of a delayed-type hypersensitivity inducer; and  
 (ii) a support; and  
   (b) instructions for using said preparation.    
     
     
         19 . The kit according to  claim 18 , wherein said kit comprises a plurality of said topical patch preparations.  
     
     
         20 . The kit according to  claim 19 , wherein said plurality of topical patch preparations are present in separate containers.  
     
     
         21 . The kit according to  claim 20 , wherein said separate containers are sealed pouches.