Drug delivery system

Abstract

The invention relates to a time controlled, immediate release drug delivery system for oral administration of a first active ingredient to a subject in need thereof. The invention additionally relates to a dual drug delivery device, comprising the time controlled, immediate release drug delivery system according to the invention, further comprising a second coating comprising a second active ingredient.

1 . A tablet for sublingual administration of a first active ingredient said tablet comprising a core, and an outer coating on the exterior surface of said tablet and optionally a separation coating that separates said outer coating from said core, wherein said outer coating comprises a mixture of
 said first active ingredient in amorphous form in an amount of between about 0.1-10 mg;   a coating polymer in an amount of between about 0.25-25 mg; and   water in an amount of between about 0.0-10% w/w of the outer coating.   
     
     
         2 . The tablet of  claim 1 , wherein the first active ingredient is testosterone or a functional analog thereof. 
     
     
         3 . The tablet of  claim 1 , wherein said mixture further comprises a cyclodextrin or a polyvinylpyrolidone, or a combination thereof in an amount of between 0.25-25 mg. 
     
     
         4 . The tablet of  claim 3 , wherein said mixture further comprises a cyclodextrin or a polyvinylpyrolidone, or a combination thereof in an amount of between 0.5-12.5 mg. 
     
     
         5 . The tablet of  claim 1 , wherein said mixture comprises said first active ingredient in an amount of between about 0.2-5.0 mg; said coating polymer in an amount of between about 0.5-12.5 mg; and water in an amount of between about 0.0-5% w/w of the outer coating. 
     
     
         6 . The tablet of  claim 1 , wherein said mixture of said outer coating further comprises a sweetener and/or a flavor. 
     
     
         7 . The tablet of  claim 1 , wherein said mixture comprises 0.5 mg of testosterone, 1.34 mg of hydroxypropyl methylcellulose, 2.66 mg of hydroxypropyl beta-cyclodextrin, 1 mg of aspartame, and 0.6 mg of menthol. 
     
     
         8 . The tablet of  claim 1 , comprising said separation coating that separates said outer coating from said core. 
     
     
         9 . The tablet of  claim 8 , wherein said core and said separation coating has a volume of between 50-1000 mm 3 . 
     
     
         10 . The tablet of  claim 8 , wherein said core comprises a cellulose, an inorganic salt and a second active ingredient. 
     
     
         11 . The tablet of  claim 8 , wherein said separation coating comprises a hydrophobic polymer and a hydrophilic substance. 
     
     
         12 . The tablet of  claim 8 , wherein said separation coating is a pH-independent coating. 
     
     
         13 . The tablet of  claim 12 , wherein said separation coating is an acid soluble coating or an enteric coating. 
     
     
         14 . The tablet of  claim 10 , which comprises a time controlled, immediate release drug delivery system for oral administration of the second active ingredient to a subject in need thereof, the system comprising
 said core comprising cellulose, a filler selected from an organic and/or an inorganic salt, and said second active ingredient, and   said separation coating surrounding the core comprising a hydrophobic polymer and a hydrophilic substance.   
     
     
         15 . The tablet of  claim 1 , wherein said second active ingredient is selected from the group consisting of a PDE5 inhibitor, a 5HT1A receptor agonist, and a neutral endopeptidase inhibitor.