Compositions

Abstract

A pharmaceutical composition for oral adminstration comprising a film-coated solid dosage form including 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide or a pharmaceutically acceptable salt or solvate thereof as active ingredient. The film-coated solid dosage forms are of use in the treatment of conditions associated with cephalic pain, in particular migraine.

1 . A pharmaceutical composition for oral administration comprising a film-coated solid dosage form including 25 to 200 mg of 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide as active ingredient or a pharmaceutically acceptable salt or solvate thereof.  
     
     
         2 . A pharmaceutical composition as claimed in  claim 1  wherein the active ingredient is in the form of its succinate (1:1) salt.  
     
     
         3 . A pharmaceutical composition as claimed in  claim 1  or  claim 2  in the form of a tablet.  
     
     
         4 . A pharmaceutical composition as claimed in  claim 3  in the form of a compression tablet.  
     
     
         5 . A pharmaceutical composition as claimed in any one of  claims 1  to  4  wherein the film coating comprises a polymer.  
     
     
         6 . A pharmaceutical composition as claimed in  claim 5  wherein the polymer is hydroxypropyl methylcellulose.  
     
     
         7 . A pharmaceutical composition as claimed in any one of  claims 1  to  6  wherein the film coating comprises 2 to 5% w/w based on the weight of the solid dosage form.  
     
     
         8 . A method of treating a mammal, including man, suffering from or susceptible to conditions associated with cephalic pain such as cluster headache, chronic paroxysmal hemicrania, headache associated with vascular disorders, headache associated with substances or their withdrawal (for example drug withdrawal), tension headache and in particular migraine which comprises oral administration of a pharmaceutical composition comprising a film-coated solid dosage form of 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide or a pharmaceutically acceptable salt or solvate thereof as active ingredient.  
     
     
         9 . A process for the preparation of a pharmaceutical composition as claimed in any one of  claims 1  to  7  which comprises applying a film coating to a solid dosage form of the active ingredient by a film coating technique.