Systems and methods for treating a mucosal surface

Abstract

A system for treating a condition associated with a mucosal surface, the system comprising an immune response modifier (IRM) compound chosen from imidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, imidazonaphthyridine amines, oxazoloquinoline amines, thiazoloquinoline amines, 1,2-bridged imidazoquinoline amines, and pharmaceutically acceptable salts thereof and an applicator device for applying the IRM compound to the mucosal surface. This system of IRM compounds and applicator may be used to treat conditions associated with mucosal surfaces such as cervical dysphasia and cervical intraepithelial neoplasia.

What is claimed is:  
     
         1 . A system for treating a condition associated with a mucosal surface, the system comprising: 
 an immune response modifier (IRM) compound chosen from imidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, 1,2-bridged imidazoquinoline amines, and pharmaceutically acceptable salts thereof; and    an applicator device for applying to the mucosal surface the IRM compound.    
     
     
         2 . The system of  claim 1 , wherein the IRM compound is 1-(2-methylpropyl)-1H-imidazo[4,5-c]-quinolin-4-amine.  
     
     
         3 . The system of  claim 1 , wherein the IRM compound is 4-amino-α,α-dimethyl-2-ethoxymethyl-1H-imidazo[4,5-c]quinoline-1-ethanol.  
     
     
         4 . The system of  claim 1 , wherein the system further comprises a pharmaceutical formulation comprising: 
 the IRM compound;    at least one fatty acid; and    a preservative system comprising propylene glycol.    
     
     
         5 . The system of  claim 1 , wherein the applicator device is pre-filled with a therapeutically effective amount of the IRM compound.  
     
     
         6 . The system of  claim 1 , wherein the IRM compound is contained in a container separate from the device.  
     
     
         7 . The system of  claim 1 , further comprising measuring marks on the applicator device for assisting a user in determining the amount of the IRM compound in the applicator device.  
     
     
         8 . The system of  claim 1 , wherein the condition associated with the mucosal surface is cervical dysplasia.  
     
     
         9 . The system of  claim 1 , wherein the mucosal surface is on a cervix.  
     
     
         10 . The system of  claim 9 , wherein the mucosal surface is on the vaginal part of the cervix.  
     
     
         11 . The system of  claim 10 , wherein the condition associated with the mucosal surface is cervical intraepithelial neoplasia.  
     
     
         12 . The system of  claim 1 , wherein the applicator device comprises: 
 a hollow tube comprising a distal delivery end and a proximal end; and    a piston slidably received within the tube.    
     
     
         13 . The system of  claim 12 , further comprising a member configured to cause movement of the piston toward the distal end.  
     
     
         14 . The system of  claim 13 , wherein the device is configured to limit retraction movement of the member toward the proximal end when the piston is located adjacent to the distal end.  
     
     
         15 . The system of  claim 13 , wherein the piston is removably coupled to the member.  
     
     
         16 . The system of  claim 13 , wherein the member is slidably received in the hollow tube.  
     
     
         17 . The system of  claim 12 , further comprising a stop limiting retraction movement of the piston toward the proximal end.  
     
     
         18 . The system of  claim 12 , wherein the piston comprises a portion extending from the distal end when the piston is positioned at its farthest location away from the proximal end.  
     
     
         19 . The system of  claim 12 , wherein the distal end is tapered on its outer surface.  
     
     
         20 . The system of  claim 13 , wherein the member has a length shorter than the distance between the proximal end and the piston when the piston is positioned at its furthest location away from the proximal end.  
     
     
         21 . A system for treating a condition associated with a mucosal surface, the system comprising: 
 an immune response modifier (IRM) compound chosen from imidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, imidazonaphthyridine amines, oxazoloquinoline amines, thiazoloquinoline amines, 1,2-bridged imidazoquinoline amines, and pharmaceutically acceptable salts thereof; and    an applicator device for applying to the mucosal surface the IRM compound.    
     
     
         22 . The system of  claim 21 , wherein the IRM compound is 1-(2-methylpropyl)-1H-imidazo[4,5-c]-quinolin-4-amine.  
     
     
         23 . The system of  claim 21 , wherein the IRM compound is 4-amino-α,α-dimethyl-2-ethoxymethyl-1H-imidazo[4,5-c]quinoline-1-ethanol.  
     
     
         24 . The system of  claim 21 , wherein the IRM compound is 2-propyl[1,3]thiazolo[4,5-c]quinolin-4-amine.  
     
     
         25 . The system of  claim 21 , wherein the system further comprises a pharmaceutical formulation comprising: 
 the IRM compound;    at least one fatty acid; and    a preservative system comprising propylene glycol.    
     
     
         26 . The system of  claim 21 , wherein the applicator device is pre-filled with a therapeutically effective amount of the IRM compound.  
     
     
         27 . The system of  claim 21 , wherein the IRM compound is contained in a container separate from the device.  
     
     
         28 . The system of  claim 21 , further comprising measuring marks on the applicator device for assisting a user in determining the amount of the IRM compound in the applicator device.  
     
     
         29 . The system of  claim 21 , wherein the condition associated with the mucosal surface is cervical dysplasia.  
     
     
         30 . The system of  claim 21 , wherein the mucosal surface is on a cervix.  
     
     
         31 . The system of  claim 30 , wherein the mucosal surface is on the vaginal part of the cervix.  
     
     
         32 . The system of  claim 31 , wherein the condition associated with the mucosal surface is cervical intraepithelial neoplasia.  
     
     
         33 . The system of  claim 21 , wherein the applicator device comprises: 
 a hollow tube comprising a distal delivery end and a proximal end; and    a piston slidably received within the tube.    
     
     
         34 . The system of  claim 33 , further comprising a member configured to cause movement of the piston toward the distal end.  
     
     
         35 . The system of  claim 34 , wherein the device is configured to limit retraction movement of the member toward the proximal end when the piston is located adjacent to the distal end.  
     
     
         36 . The system of  claim 34 , wherein the piston is removably coupled to the member.  
     
     
         37 . The system of  claim 34 , wherein the member is slidably received in the hollow tube.  
     
     
         38 . The system of  claim 33 , further comprising a stop limiting retraction movement of the piston toward the proximal end.  
     
     
         39 . The system of  claim 33 , wherein the piston comprises a portion extending from the distal end when the piston is positioned at its farthest location away from the proximal end.  
     
     
         40 . The system of  claim 33 , wherein the distal end is tapered on its outer surface.  
     
     
         41 . The system of  claim 34 , wherein the member has a length shorter than the distance between the proximal end and the piston when the piston is positioned at its furthest location away from the proximal end.  
     
     
         42 . A method for treating a condition associated with a mucosal surface, the method comprising: 
 providing an immune response modifier (IRM) compound chosen from imidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, imidazonaphthyridine amines, oxazoloquinoline amines, thiazoloquinoline amines, 1,2-bridged imidazoquinoline amines, and pharmaceutically acceptable salts thereof;    providing an applicator device for applying to the mucosal surface the IRM compound; and    applying the IRM compound to the mucosal surface with the applicator device.    
     
     
         43 . The method of  claim 42 , wherein the IRM compound is 1-(2-methylpropyl)-1H-imidazo[4,5-c]-quinolin-4-amine.  
     
     
         44 . The method of  claim 42 , wherein the IRM compound is 4-amino-α,α-dimethyl-2-ethoxymethyl-1H-imidazo[4,5-c]quinoline-1-ethanol.  
     
     
         45 . The method of  claim 42 , wherein the IRM compound is 2-propyl[1,3]thiazolo[4,5-c]quinolin-4-amine.  
     
     
         46 . The method of  claim 42 , wherein the applicator device is pre-filled with a therapeutically effective amount of the IRM compound.  
     
     
         47 . The method of  claim 42 , further comprising filling the applicator device with the IRM compound, wherein the IRM compound is contained in a container separate from the device.  
     
     
         48 . The method of  claim 47 , wherein the applicator device comprises measuring marks and wherein the method further comprises using the marks to determine the amount of the IRM compound in the applicator device.  
     
     
         49 . The method of  claim 42 , further comprising: 
 inserting the applicator device into the vagina;    positioning a distal end of the applicator device adjacent to the mucosal surface; and    applying the IRM compound to the mucosal surface, wherein the mucosal surface is on a cervix.    
     
     
         50 . The method of  claim 42 , further comprising positioning a distal end of the applicator device adjacent to the vaginal part of the cervix, and applying the IRM compound to the mucosal surface, wherein the mucosal surface is on the vaginal part of the cervix.  
     
     
         51 . The method of  claim 42 , wherein the condition associated with the mucosal surface is cervical intraepithelial neoplasia.  
     
     
         52 . The method of  claim 42 , wherein the applicator device comprises a hollow tube comprising a distal delivery end and a proximal end, and a piston slidably received within the tube and wherein the method comprises moving the piston in the tube to cause dispensing of the IRM compound via the distal end.  
     
     
         53 . The method of  claim 52 , wherein the applicator device further comprises a member configured to cause movement of the piston toward the distal end, and wherein the method comprises moving the member to cause the movement of the piston.  
     
     
         54 . The method of  claim 53 , further comprising limiting retraction movement of the member toward the proximal end when the piston is located adjacent to the distal end.  
     
     
         55 . The method of  claim 53 , wherein the piston is removably coupled to the member and wherein the method further comprises uncoupling the member from the piston.  
     
     
         56 . The method of  claim 53 , further comprising sliding the member in the hollow tube.  
     
     
         57 . The method of  claim 52 , further comprising limiting retraction movement of the piston toward the proximal end.  
     
     
         58 . The method of  claim 52 , further comprising extending a portion of the piston from the distal end when the piston is positioned at its farthest location away from the proximal end.