Pharmaceutical paste formulations for site specific application

Abstract

A pharmaceutical paste formulation containing an active ingredient, an API solubilizer, a cross-linking agent, a consistency improver, a rheology modifier, a humectant, and a liquid base.

1 . (canceled) 
     
     
         2 . A medical device comprising:
 a squeezable reservoir containing a pharmaceutical gel formulation; and   a site-specific applicator projecting from the reservoir,
 said site specific applicator presenting a proximal end and a distal end, 
 said site-specific applicator including a wall defining an inner margin extending between the proximal end and the distal end, 
 said inner margin having a width ranging from 0.5 mm to 2 mm, 
 said inner margin defining an opening at the distal end, 
 said inner margin being arranged in fluid communication with the reservoir such that the sucralfate formulation is expelled therethrough and out of the opening when the reservoir is squeezed, 
 wherein said pharmaceutical gel formulation has a sucralfate concentration ranging from 3% w/w to about 15% w/w. 
   
     
     
         3 . The medical device as claimed in  claim 2 , said squeezable reservoir being in the shape of a tube. 
     
     
         4 . The medical device as claimed in  claim 2 , wherein said pharmaceutical gel formulation is capable of being stored in said squeezable tube for a period of time of 1-year, and wherein said pharmaceutical gel formulation is capable of being expelled from the squeezable reservoir through the inner margin throughout the period of time. 
     
     
         5 . The medical device as claimed in  claim 4 , said period of time is 2-years. 
     
     
         6 . The medical device as claimed in  claim 2 , said site-specific applicator having a conical shape. 
     
     
         7 . The medical device as claimed in  claim 2 , said inner margin having a circular shape. 
     
     
         8 . The medical device as claimed in  claim 7 , said inner margin presenting a diameter in the range from 0.5 mm to 2 mm. 
     
     
         9 . The medical device as claimed in  claim 2 , said width being about the same along the inner margin. 
     
     
         10 . The medical device as claimed in  claim 2 , wherein said site-specific applicator is removably fixed to the reservoir. 
     
     
         11 . The medical device as claimed in  claim 2 , further comprising a removable closure arranged at the distal end of the site-specific applicator. 
     
     
         12 . The medical device as claimed in  claim 2 , said pharmaceutical gel formulation further comprising:
 malic acid, as an API solubilizer, in a concentration ranging from about 4.8% w/w to about 5.2% w/w;   calcium carbonate, as a cross-linking agent, in a concentration ranging from about 2.4% w/w to about 2.6% w/w;   calcium sulfate dihydrate, as a consistency improver, in a concentration ranging from about 0.05% w/w to about 1.5% w/w;   xanthan gum, as a rheology modifier, in a concentration ranging from about 0.1% w/w to about 1.0% w/w; and   propylene glycol, as a humectant, in a concentration ranging from about 2% w/w to about 10% w/w.   
     
     
         13 . The medical device as claimed in  claim 2 , wherein said pharmaceutical formulation has a water content ranging from an about 56% w/w to about 85% w/w. 
     
     
         14 . The medical device as claimed in  claim 2 , said pharmaceutical gel formulation further comprising sucralose, as a sweetener. 
     
     
         15 . The medical device as claimed in  claim 2 , wherein said reservoir and said site-specific applicator being formed from a copolymer. 
     
     
         16 . The medical device as claimed in  claim 2 , said reservoir comprising an inner layer and an outer layer. 
     
     
         17 . The medical device as claimed in  claim 16 , said inner layer comprising an aluminum alloy. 
     
     
         18 . The medical device as claimed in  claim 16 , said outer layer comprising polyethylene. 
     
     
         19 . The medical device as claimed in  claim 16 , said reservoir further comprising a tie-layer arranged between the inner layer and the outer layer. 
     
     
         20 . The medical device as claimed in  claim 19 , said tie-layer comprising an ethylene acrylic acid copolymer.