Fast dissolving pharmaceutical composition

Abstract

The subject invention is directed to a pharmaceutical composition comprising an open matrix network carrying a pharmaceutically active ingredient, wherein the open matrix network comprises both the polysaccharides levan and inulin.

1 . A pharmaceutical composition comprising:
 a) an open matrix network comprising levan and inulin; and   b) at least one pharmaceutically active ingredient carried by the open matrix network.   
     
     
         2 . A pharmaceutical composition comprising:
 a) a matrix carrying at least one pharmaceutically active ingredient; and   b) the matrix comprising levan and inulin,   wherein the matrix rapidly disintegrates upon contact with an aqueous medium or with saliva.   
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the matrix further comprises mannitol. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein the matrix further comprises trehalose. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the matrix further comprises raffinose. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein at least 80% of the composition is dissolved in an aqueous medium or saliva within 30 seconds. 
     
     
         7 . The pharmaceutical composition according to  claim 6 , wherein at least 80% of the composition is dissolved in an aqueous medium or saliva within 10 seconds. 
     
     
         8 . The pharmaceutical composition according to  claim 1  having a tensile strength of about 0.05-1.6 N/mm 2  and a rapid dissolution rate such that at least 80% of the composition is dissolved in an aqueous medium or saliva within 30 seconds. 
     
     
         9 . The pharmaceutical composition according to  claim 8 , wherein the composition is dissolved in an aqueous medium or saliva within seconds. 
     
     
         10 . The pharmaceutical composition according to  claim 1 , in an oral dosage form. 
     
     
         11 . The pharmaceutical composition according to  claim 10 , which is adapted for sublingual administration. 
     
     
         12 . The pharmaceutical composition according to  claim 1  obtainable by subliming a solvent from a liquid preparation comprising the active ingredient and levan and inulin in a solvent. 
     
     
         13 . The pharmaceutical composition according to  claim 12 , wherein the sublimation is carried out by freeze drying the preparation. 
     
     
         14 . The pharmaceutical composition according to  claim 1 , wherein the active ingredient is desmopressin or desmopressin acetate. 
     
     
         15 . The pharmaceutical composition according to  claim 1 , wherein the active ingredient is loratidine. 
     
     
         16 . The pharmaceutical composition according to  claim 1 , wherein the active ingredient is famotidine. 
     
     
         17 . The pharmaceutical composition according to  claim 1 , wherein the active ingredient is montelukast sodium. 
     
     
         18 . The pharmaceutical composition according to  claim 1 , wherein the active ingredient is ondansetron. 
     
     
         19 . A process for preparing a pharmaceutical composition comprising subliming a solvent from a liquid preparation comprising a pharmaceutically active ingredient and levan and inulin in the solvent. 
     
     
         20 . The process according to  claim 19 , comprising: (a) introducing unit dosage quantities of said liquid preparation into depressions of an open blister pack; and (b) subliming the preparation to obtain solid unit dosage forms within said depressions. 
     
     
         21 . The process according to  claim 20 , wherein the sublimation is carried out by freeze drying the preparation. 
     
     
         22 . The process according to  claim 21 , wherein the solvent is water. 
     
     
         23 . The process according to  claim 19 , wherein the active ingredient is desmopressin or desmopressin acetate. 
     
     
         24 . The process according to  claim 19 , wherein the active ingredient is loratidine. 
     
     
         25 . The process according to  claim 19 , wherein the active ingredient is famotidine. 
     
     
         26 . The process according to  claim 19 , wherein the active ingredient is montelukast sodium. 
     
     
         27 . The process according to  claim 19 , wherein the active ingredient is ondansetron. 
     
     
         28 . A process for the preparation of a pharmaceutical composition comprising:
 (a) preparing a solution comprising levan, inulin and an active ingredient in a solvent;   (b) freezing said solution;   (c) subliming the solvent from the frozen, solution,   
       wherein the pharmaceutical composition so obtained disintegrates within 30 seconds upon contact with an aqueous solution or saliva. 
     
     
         29 . The process according to  claim 28 , wherein the pharmaceutical composition obtained disintegrates within 10 seconds upon contact with an aqueous solution or saliva. 
     
     
         30 . (canceled)