Dispersible compositions

Abstract

The present invention is concerned with dispersible compositions comprising rilpivirine or a pharmaceutically acceptable acid addition salt thereof as an active ingredient. Such compositions are useful in the treatment of HIV infection and their dispersibility properties lend themselves to be useful in particular amongst the pediatric or geriatric population.

1 . A dispersible composition comprising E-4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]-benzonitrile (rilpivirine) or a pharmaceutically acceptable acid addition salt thereof, as the active ingredient, wherein said active ingredient is present in the dispersible composition in the form of granules, said granules further comprising a pharmaceutically acceptable excipient; wherein the dispersible composition comprises 2.5 mg base equivalent of E-4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]-benzonitrile; and wherein the dispersible composition further comprises next to the granules, in the extragranular fraction, a non-soluble diluent. 
     
     
         2 . The dispersible composition according to  claim 1  wherein the pharmaceutically acceptable excipient of the granules comprises a wetting agent. 
     
     
         3 . The dispersible composition according to  claim 1  wherein the pharmaceutically acceptable excipient of the granules comprises a disintegrant. 
     
     
         4 . The dispersible composition according to  claim 1  wherein the pharmaceutically acceptable excipient of the granules comprises a diluent. 
     
     
         5 .- 6 . (canceled) 
     
     
         7 . The dispersible composition according to  claim 1  comprising in the extragranular fraction a wetting agent. 
     
     
         8 . The dispersible composition according to  claim 1  comprising in the extragranular fraction a disintegrant. 
     
     
         9 . The dispersible composition according to  claim 1  wherein the composition is a tablet. 
     
     
         10 . The dispersible composition according to  claim 1  wherein the active ingredient is rilpivirine HCl. 
     
     
         11 .- 13 . (canceled) 
     
     
         14 . A combination comprising a dispersible composition according to  claim 1  and one or more other therapeutic agents useful in the treatment of HIV infection. 
     
     
         15 . A method of treating a patient suffering from HIV infection comprising administering to the patient a therapeutically effective amount of a dispersible composition according to  claim 1 . 
     
     
         16 . The method of  claim 15 , wherein the dispersible composition is administered in combination with one or more other therapeutic agents useful in the treatment of HIV infection. 
     
     
         17 . The method of  claim 15 , wherein the patient is a pediatric patient or a geriatric patient.